276 Clinical Data Jobs - Page 6

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required. At least 5 years programming experience in industry. Demonstrated proficiency in using SAS to produce derived analysis datasets and TFLs. Have in-depth understanding of clinical data structure (e. g. CDISC standards) and relational database. Demonstrated skills in using software tools and applications, e. g. , MS office, XML, Pinnacle 21. Demonstrated ability in the handling and processing of upstream data, e. g. , multiple data forms, workflow, eDC, SDTM. Demonstrated ability in providing outputs to meet downstream requirements, e. g. , ADaM, Data Definition Table, e-submission. Have good understanding of regulatory, industry, and technology standards and requirements. Have good knowledge of statistical terminology, clinical tests, medical terminology and protocol designs. Demonstrated ability to work in a team environment with clinical team members. Preferred Requirements: Minimum of 5 years clinical / statistical programming experience within pharmaceutical clinical development - Supporting regulatory filings (e. g. NDA, BLA, MAA) Knowledge of the drug development process, clinical trial methodology, statistics and familiarity with global regulatory requirements Experience in other software packages (e. g. R) Experience with the Linux operating system If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Statistical Programmer - R Programmer (Remote opportunity) Company: Element Technologies Location: Remote (India) Experience: 6 to 10 years About the Role: Element Technologies is hiring a Statistical Programmer with strong R programming experience to join our growing team. This is a remote opportunity tailored for professionals passionate about clinical data analysis and programming, with expertise in CDISC standards. Key Responsibilities: Develop, validate, and maintain SDTM, ADaM datasets, and TLFs as per CDISC guidelines Perform efficacy analyses using R programming Work independently on studies and support clinical trial submissions Collaborate with cross-functional teams in an FSP environment Debug and utilize standard macros efficiently Preferred involvement in integrated summaries (ISS/ISE) Must-Have Skills: 6 to 8 years of relevant experience in statistical programming Minimum 3 years of hands-on experience with R programming Strong knowledge and working experience with CDISC standards: SDTM, ADaM, and TLF Exposure to efficacy analysis Study-level handling experience (for senior-level profiles) Preferred Skills: Experience with CRT package (Trial Data Domain) Prior involvement in ISS and ISE Experience in an FSP environment Familiarity with standard macro debugging and utilization Why Join Us? 100% Remote Role Be part of a specialized Data Science and Clinical Programming team Opportunity to work on impactful global healthcare projects ,

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationship Roles and Responsibilities: Update BOT query sheet as and when requested by the TDM.Ensure completeness and validity of clinical as well as external data.Generate missing page report and track missing pages, as required.Track discrepancy and query status of assigned studies/Investigative sites as applicable.Review data from first data received to last data received and for selected tasks supporting the interim analysis/final database lock by operating in a continuous cleaning process.Perform DD pass activities as needed.Perform review for SDTM Data sets (SITS), P21 and other applicable reports.Share the weekly study metrics with TDM.Act as back up for TDM and lead study related meetings/document MOM and perform task allocation applicable for Data Manager, as needed.Upload standard reports/manual listings (DQPM listings) to central client location as guided by Lead Data Manager or client counterparts.Maintain an issue log to track and resolve discrepancies. Ensure issue clarification/follow-up until closure per the Issue Escalation Process/guidelines, as applicable.Interact with the TDM/Lead regarding data quality issues and assist them in tracking, monitoring the progress of data review activities.Accountable for high quality and on time delivery for assigned deliverables.Achieve the applicable SLA/KPI metrics. Qualification Bachelor of Pharmacy

Brief Position Description: The core responsibility for this position is as a member of the Data Management department at Novotech. The (Senior) Clinical Data Programmer will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience: Graduate in information science or life science related field, or similar. Two years experience in a similar role in a CRO or pharmaceutical company. Preferably with hand-on experience with Custom Functions/C# and Veeva EDC. Responsibilities: The Clinical Data Programmer shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP shall ensure quality standards per SOPs and ICH-GCP. The CDP shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards. Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards. Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. Experience in developing, validating and maintaining clinical trials built in different EDC applications. Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. Brief Position Description: The core responsibility for this position is as a member of the Data Management department at Novotech. The (Senior) Clinical Data Programmer will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). Minimum Qualifications & Experience: Graduate in information science or life science related field, or similar. Two years experience in a similar role in a CRO or pharmaceutical company. Preferably with hand-on experience with Custom Functions/C# and Veeva EDC. Responsibilities: The Clinical Data Programmer shall be responsible for programming activities on a project. This shall include designing and implementation of clinical database, programming of data review listings and programming of data reconciliation. The CDP shall ensure quality standards per SOPs and ICH-GCP. The CDP shall be responsible for designing, programming, testing and maintenance of clinical trial databases in different clinical trial applications in accordance with Novotech standards. Perform external data loads, i.e. labs, ECGs etc., as needed. Act as liaison with vendors to establish data transfer specifications standards. Ensure all programming activities and processes performed are conducted in accordance with standard operating procedures and good programming practices. Experience in developing, validating and maintaining clinical trials built in different EDC applications. Annotate CRFs in accordance with CDISC published or sponsor specific guidelines with appropriate metadata to reflect case report tabulation (CRT) data sets Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application.

Provide medical expertise on pharmacovigilance services to divisions as requested. The Associate Medical Safety Director participates in all aspects of Medical Safety s involvement on assigned trials and stand alone safety projects with appropriate oversight from management or more senior medical safety directors. Essential Functions Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality and company summary Compose, edit and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product s safety profile Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data Represent safety and clinical data review findings during client meetings Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies Provide medical oversight for label development, review and change Provide medical support and attendance at Data Safety Monitoring Board Meetings Attends and contributes medical safety evaluation on Safety Monitoring Committees Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document Provide medical review and edits to Drug Safety Reports or other benefit-risk assessments Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture. Act as Global Safety Physician or Assistant or Back-up on projects as assigned Attend project meetings, medical safety team meetings, and client meetings as requested Ensure coverage for all medical safety deliverables within regulatory or contracted timelines Provide medical escalation support for medical information projects Provide medical escalation support for EU Qualified Persons for Pharmacovigilance projects 24 hour medical support as required on assigned projects Maintain awareness of medical-safety-regulatory industry developments Line manage a team of regionally based physicians performing the tasks of a global medical safety physician ensuring operational delivery of assigned projects and professional development of direct reports Participate in the Global Medical Safety Management Team to drive service line growth, differentiation, and strategy Represent global medical safety service line to regional stakeholders, internal and external Hold at least bi-monthly meetings with direct reports to discuss, at a minimum: project status, including timelines, delivery updates, financial aspects of the group or project, and potential risks, associated mitigation and support required; status of any initiatives that they may be involved in; the teams utilization rates; the direct reports training and other administrative obligations, such as Standard Operating Procedures (SOPs) and corporate training mandates; personnel issues; and career or training objectives. Create and implement plans for measuring and improving employee engagement ensuring global consistency. Maintain open and regular communication with direct reports to ensure a supportive working environment. Efficiently conveying messages from leadership to direct reports and teams, as well as effectively communicating issues and opportunities up to leadership. Might be needed to serve as the designated substitute or alternatively ensure coverage is in place for direct reports during their absence or in case of turnover. Prepare, present and respond in bid defense meetings and discussions. May input into more complex requests for information (RFIs) or requests for proposal (RFPs). Liaise with Business Development to give timely inputs regarding the feasibility of all new proposals going out to clients. Contribute at IQVIA internal cross-functional project team meetings interfacing with other functional leads customer project status meetings and oversight group meetings. Subject Matter Expert (SME) Meetings, as appropriate. Qualifications Other A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education Req Three (3) years of clinical practice experience (e.g graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role. Or equivalent combination of education, training and experience Req Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice Knowledge of clinical trials and pharmaceutical research process Strong business acumen; financial management and budgeting skills. Proven Staff management skills, strong leadership, motivational and influencing skills. Strong project management; strategic planning; delegation and organisational skills. Proven ability to work on multiple projects and manage competing priorities. Confident in raising and discussing sensitive topics without management intervention and in communicating effectively with senior levels of management in both IQVIA and customer organizations. Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues. Excellent communication (both verbal and written), presentation and negotiation skills. Ability to establish and maintain effective working relationships with coworkers, direct reports, managers, and customers at a senior level. Autonomous independent decision-making; problem solving and judgment skills. Strong customer focus; account and alliance management and experience in customer contracting models. Proven ability to professionally network; present and lead at meetings/ teleconferences. Ability to achieve results through communication, facilitation, negotiations in a matrix service delivery environment with shared responsibilities. Demonstrate excellent flexibility; self-motivation; creativity; innovation and solutions driven approach. Demonstrates financial awareness. Promotes good practices to manage financial performance Strong ownership skills: take initiative and move forward with limited guidance. A valid medical license, or equivalent, from the country or region in which he/she resides and works Pref

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Responsibilities will include, but are not limited to: Data Review : Understand and review Protocol along with relevant study specific data review documents. Provide input to data review documents like Protocol Data Review Plan, Data Quality Management Plan Review clinical data listings and prioritize critical data review. Manage and facilitate resolution of data discrepancies. Perform data cleaning as per the defined Clean Patient Group. Freezing & Locking of CRFs/Fields. Coordinate with Data Management Lead for study deliverables. External Data: Track data load and address discrepancies. Complete review of loaded external data and prioritize complex external data review e.g. Blinded Independent Committee Review, Biomarker, SAE Coordinate with external data vendor for resolution of data discrepancies as applicable. Documentation: Filing of appropriate documents in eTMF as per eTMF master plan. Training and Mentorship: Provide Training and mentoring to junior CDM staff. Bachelor s Degree required. Life sciences, Pharmacy or relevant fields preferred. 4 years of experience in Clinical Data Review tasks Able to work on clinical data review tasks Able to work collaboratively on multi-disciplinary project teams. Strong knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management Strong knowledge and experience of EDC systems (Medidata RAVE preferred); demonstrated knowledge of Microsoft Office skills. Strong oral and written communication skills. Yes, 5-10% Industry Conferences, Investigator Meetings, Regulatory Inspections (as needed) With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Key Responsibilities Project Responsibilities: Provides comprehensive programming leadership and support to clinical project teams and vendors, including deployment of programming strategies, standards, specifications and programmed analysis to comply with regulatory requirements, SOPs and work practices Independently develops, validates, troubleshoots, and maintains complex programs and utilities in accordance with predefined specifications and standards Leads / Supports the electronic submission preparation and review Develops unambiguous and robust programming specifications (e. g. ADaM specifications) Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to align with project objectives and ensures clarity and completeness of programming assumptions and requirements; Assesses document robustness and impact on programming activities Communicates proactively and effectively around issues and risks and contributes to its remediation Improvement Responsibilities: Identifies, leads, and supports opportunities to enhance processes and technology Communicates proactively and effectively around issues and risks and contributes to its remediation Managerial Responsibilities (if applicable): Effectively recruits, manages, develops, evaluates, rewards, motivates, and retains up to 5 direct reports, resulting in an increasing level of capabilities within GBDS Conducts objective setting, performance check-ins, and year-end discussions in compliance with BMS policies; aligns objectives, feedback and performance evaluation with manager Meets regularly with direct reports, focusing on project updates, development needs, issue resolution, and provides real-time coaching and feedback; holds staff accountable for quality and timeliness of programming activities; ensures staff is compliant with training requirements Communicates with manager regarding promotions, performance concerns, and retention risks Builds and maintains a network with stakeholders and peers to ensure cross-functional strategies and objectives intertwine and build upon each other to achieve results. Skills, knowledge, and experience Minimum Requirements: Bachelor s degree in statistics, biostatistics, mathematics, computer science or life sciences required At least 8 years programming experience in industry including support of significant regulatory filings Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry standards, statistical concepts, and medical terminology used in the analysis and submission of clinical data Broad expertise in statistical programming and in developing computing strategies In-depth understanding of clinical data structure (e. g. CDISC standards) and relational databases Demonstrated proficiency in using SAS to produce analysis datasets and TFLs and in using other software tools and applications (e. g. MS office, XML, Pinnacle 21) Demonstrated ability in processing of upstream data (e. g. multiple data forms, workflows, eDC, SDTM); Demonstrated ability in providing deliverables to meet downstream requirements, (e. g. ADaM, TFLs, e-submission components) Demonstrated ability to work in a team environment with clinical team members Preferred Requirements: Management experience supervising technical professionals If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

POSITION PURPOSE: As an Regional Medical Advisor Lead (RMA Lead), you will serve as the primary scientific and strategic leader for medical affairs activities within your therapy areas. You will lead a team of Regional Medical Advisors, driving the execution of medical strategies, fostering strong relationships with Key Opinion Leaders (KOLs), and ensuring the delivery of high-quality scientific support to internal and external stakeholders. Your role is pivotal in aligning medical insights with organizational goals to optimize patient outcomes and advance the company s presence in the therapeutic areas. YOUR TASKS AND RESPONSIBILITIES: Leadership & Team Management: Lead, mentor, and develop a team of Regional Medical Advisors to ensure consistent delivery of medical affairs objectives Oversee team activities including KOL engagement, medical education, and evidence generation, ensuring alignment with the strategic medical affairs plan Foster a collaborative and high-performance culture within the team, promoting continuous learning and professional growth Scientific Leadership & KOL Engagement: Act as the primary scientific face of the organization to KOLs, physicians, and other stakeholders Drive identification, mapping, profiling, and engagement of KOLs, ensuring ongoing relationship management and collaboration Represent the organization at internal and external scientific platforms, advisory boards, and conferences Strategic Medical Affairs Execution: Lead the development and execution of regional medical affairs strategies, including medical education, product training, advisory boards, pre-license activities, and special projects Representing the organization in various internal & external scientific platforms Collaborate closely with therapy area leads and cross-functional teams to support evidence generation, data dissemination, and communication of scientific insights Proactively analyze disease trends, treatment patterns, and competitive landscape to inform strategy and decision-making Scientific Expertise & Communication: Provide expert scientific support to healthcare professionals, addressing complex queries related to products and therapeutic areas Facilitate peer-to-peer scientific discussions and training sessions for the sales and medical teams Collaborate with KOLs on research initiatives such as meta-analyses, case studies, and publications in reputed journals Compliance & Governance: Ensure all medical affairs activities comply with the company s Global Code of Conduct and regulatory guidelines Maintain accurate documentation and reporting of medical interactions and activities WHO YOU ARE: Experience: Minimum 5 years in pharmaceutical medical affairs or related scientific roles. Academic Background: MBBS + MD Pharmacology Deep knowledge of medical research methodologies, clinical data interpretation, and therapeutic area insights Proven ability to lead, motivate, and develop a high-performing team in a complex business environment Excellent interpersonal, presentation, and scientific communication skills, capable of engaging with senior healthcare professionals and KOLs Ability to analyze trends, generate insights, and contribute to strategic planning Strong commitment to ethical standards and regulatory compliance

Skill required: Clinical Data Services - Clinical EDC Build Designation: Clinical Data Svs Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 3 to 5 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop clinical study databases by building electronic case report forms and program edit checks as per specifications. Support any updates or changes to the study database (e.g. Protocol amendments) through the change control process. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Clinical Database Developers:Overall experience of 4+ years with exposure to EDC platforms like Medidata RAVE EDC, Inform, Oracle Clinical, Veeva etc. preferred.Extensive experience in database design, edit check programming, custom function programming and unit testing.Experienced in various modules such as IVRS/RWS integration and Lab administration. Medidata RAVE study builder certified preferred. Qualification BSc,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical data svs analyst Qualifications: BE,BTech,MCA Years of Experience: 3-5 yrs About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, Clinical Automation, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Automation Team focuses on the development and implementation of innovative concepts and application for out clients across different accounts in Operations. The team is responsible for designing and implementing highly interactive, scalable web apps and prototypes at Enterprise level. The team is responsible for collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You will be expected to develop and implement complex APIs based on requirements using different tools/techs such as .Net, Java, PL/SQL, C# or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamBachelors degree in computer science, Information Technology, Engineering or any computer related discipline.Work experience of at least 3 years in relevant industries (Financial Services, Network, Utilities, Health Care, Marketing, Pharma, Retail etc.).Work experience of at least 4 years in designing, coding, APIs, testing, debugging, documenting, and implementing enhancements and fix solutions.Work experience in Implementing APIs based architecture frameworks.Aptitude to learn, think creativity to solve real world business problems, and work in a global collaborative team environment.Proficient verbal and written communication skills in English. Roles and Responsibilities: Work as a technical lead to architect and develop innovative concepts and applications for our clients across different accounts in Operations.Design and implement highly interactive, scalable web apps and prototypes at Enterprise level.Build and modify high-performance APIs and Monitor API performance and troubleshoot issues promptly.Implement APIs based on architecture frameworks and guidelines.Work with DevOps engineers to integrate new code into existing continuous integration (CI) and continuous delivery/deployment (CD) pipelines.Able to lead Automation initiatives within his account.Work closely with the team and client to understand requirements and guiding them to deliver the most effective solution.Participate in the development of automation solutions, from prototyping new functionality and technologies to integrating them in our overall products and offerings, thus developing expertise and skills in this domain.Collaborate with frontend and backend developers to define API requirements and Ensure API security and authentication mechanisms are robust.You should be able to pilot and deploy automation solutions at scale.Partner with the testing team to ensure applications/components are fully functional.Oversee and fix any defects or performance problems discovered in testing.Participating in analyses of requirements as well as functional design whenever necessary.Be involved in the design of the solution.Performing design, coding, application maintenance and testing activities.Take ownership of the successful implementation of the solution.Interact with the end client as required to ensure the solution is implemented as per requirements.Deliver code to time and quality expectations.Fully unit test developed solutions. Qualification BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Database Programming Designation: Clinical Data Svs Sr Analyst Qualifications: BSc/Master of Pharmacy Years of Experience: 5 to 8 years Language - Ability: English(International) - Expert About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.You will be expected to develop and review complex edit checks, patient profile listings, reports, preprocessing checks & map datasets for validation based on study requirements using different tools/techs such as Cognos / SAS, J-Review, or any other applicable systems. What are we looking for Adaptable and flexibleAbility to perform under pressureProblem-solving skillsDetail orientationAbility to establish strong client relationship Roles and Responsibilities: Data Review Report Programmers:Overall experience of 4+ years in Clinical review and reporting programming, business analytics and/or clinical trial setup, gained in the pharmaceutical industry, CRO or Life Science related industry preferred.Participate in the lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support.Provide understandable and actionable reports on clinical data and monitoring of clinical data for key stakeholders.Facilitate interaction with end user on creating specifications and working with programmers or performing the programming activities for successful delivery.Program reports of various complexity from documented requirements, within the clinical reporting systems using SQL, PL/SQL, SAS, and JReview etc. preferred. Qualification BSc,Master of Pharmacy

Skill required: Clinical Data Services - Clinical Data Management Designation: Clinical Data Svs Sr Analyst Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.A critical phase in clinical research that assures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). What are we looking for Ability to establish strong client relationshipAbility to handle disputesAbility to manage multiple stakeholdersAbility to meet deadlinesAbility to work well in a team Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Position Summary: We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER s that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 4 - 6 years with a minimum of 1 - 2 years of CER writing experience is essential. A minimum of 1 - 2 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Preferred Education: Masters degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 4 - 6 years of CER writing and reviewing experience. Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1. 2. Knowledge in the therapeutic area - specifically in the field of diagnostic radiology, interventional radiology and radiation oncology 3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations. Duties and Responsibilities 1. Collaborate with the project/program stakeholders for product knowledge and information to develop quality content for the CER s and within the required timelines. 2. Screen and summarize literature for relevant clinical data 3. Review literature to elucidate the clinical problem and current treatment techniques 4. Study and report device characteristics and instructions for use 5. Evaluate data for similar competitor devices 6. Summarize post-marketing surveillance and risk management data for the target device 7. Able to work in cross functional teams with strong communication, presentation & interpersonal skills 8. Analytical thinking skills with strong demonstration of scientific writing and verbal communication.

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for Clinical Database ProgrammingClinical Data ManagementOracle Procedural Language Extensions to SQL (PLSQL)Adaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to work well in a teamSAS ClinicalStructured Query Language (SQL) Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Sr Analyst Qualifications: BE/BTech/MCA Years of Experience: 5 to 8 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

We are seeking a highly skilled Biostatistician to join our team in Hyderabad. In this role, you will provide expert support and functional and technical knowledge to ensure the scientific integrity and validity of clinical development, early development, and/or research projects. You will play a crucial part in the full lifecycle of producing key data and reports, from evaluating requirements to coordinating validation and providing quantitative analytical support. This position also involves providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. You may also contribute statistical expertise to research or other R&D areas. Additionally, you'll be responsible for advising and leading the planning, development, and implementation of industry (CDISC and regulatory) compliant, high-quality clinical data standards, infrastructure, or automation technologies. You will provide expert support and stellar customer focus to business users and teams on their use of various data-related tools and processes. About the Role: Key Responsibilities Study Level Responsible for all statistical tasks on assigned trials, performing mid- to high-complexity trials independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plans, and reporting activities. Contribute to planning and execution of exploratory analyses, PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive, and implement novel methods and innovative trial designs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities, and other drug development activities as required. Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions, explaining statistical concepts clearly to non-statisticians and providing adequate statistical justifications for actions/decisions/statements when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. Ensure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project Level May be a core member of an early project team for a low-complexity program, representing Biostatistics and Pharmacometrics as part of the development plan with oversight. Collaborate with clinical, regulatory, and other strategic functions to drive quantitative decision-making in assigned indications/programs with oversight. Collaborate cross-functionally (e.g., data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization, and tracking of program-level biostatistics activities and effective partnership with vendors. Significantly contribute to project team preparation for Health Authority (HA) Advisory Committees and meetings. Franchise or Global Line Function Level Significantly contribute to initiatives at the global line function level. Enterprise Level Actively contribute to cross-functional organizational/process/scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and acceptance of innovative methods within and outside the organization, through scientific collaborations, publications in scientific peer-reviewed journals, presentations, and chairing sessions at professional meetings. External Level Contribute to interactions with external review boards/ethics committees, external consultants, and other external parties with appropriate oversight. Represent Novartis in statistical discussions at external congresses, conferences, and scientific meetings. Role Requirements MS (in Statistics or equivalent) with 7+ years of relevant work experience OR PhD (in Statistics or equivalent) with 3+ years of relevant work experience . Fluent English (oral and written) with good communication and presentation skills. Ability to influence decisions that directly impact the trial/project and team's ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modeling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in the use of statistical software packages (e.g., SAS, R ). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and/or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Adherence to good business ethics.

In this pivotal role based in Hyderabad, you will lead an Agile product squad, taking ownership of the vision, strategy, and implementation for our Clinical Data products, specifically supporting Amgen's Clinical Trial Design & Analytics. You'll be a key collaborator, working closely with statisticians, data scientists, data engineers, and AI/ML engineers to translate business needs into system enhancements and drive successful implementation projects. Your robust background in business analysis, system design, and project management will be crucial in delivering innovative and impactful technology products. Roles & Responsibilities Define and communicate the product feature vision , encompassing both technical/architectural and end-user features, ensuring alignment with business objectives across multiple solution collaborator groups. Create, prioritize, and maintain the feature backlog , ensuring it accurately reflects business and collaborator needs. Collaborate with collaborators to gather and document product requirements, user stories, and acceptance criteria . Work closely with business teams, Scrum Master, and the development team to plan and implement sprints, ensuring the delivery of the highest priority features. Oversee the day-to-day management of technology platforms, ensuring they meet performance, security, and availability requirements . Ensure platforms comply with security standards, regulatory requirements, and organizational policies . Assure that the AIN team successfully creates robust written materials, including product documentation, product backlog, and user stories , and other necessary artifacts for efficient and effective cross-time zone coordination. Oversee the resolution of service-related incidents and problems, ensuring minimal impact on business operations. Maintain in-depth knowledge of clinical development business domains , with an emphasis on data assets and data pipelines, and an understanding of multi-functional dependencies. Analyze customer feedback and support data to identify pain points and opportunities for product improvement. What We Expect of You We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications Master's degree and 8 to 10 years of Information Systems experience OR Bachelor's degree and 10 to 14 years of Information Systems experience OR Diploma and 14 to 18 years of Information Systems experience A solid foundation in modern software design and engineering practices and business analysis . Proven experience in understanding and gathering business requirements, delivering insights, and achieving concrete business outcomes. Technical Proficiency : Good understanding of the following technologies: Python, R, AI/ML frameworks, relational databases/data modeling, AWS services (EC2, S3, Lambda, ECS, IAM), Docker, CI/CD/Gitlab, Apache/Databricks . Expert understanding and experience of the clinical development process within Life Sciences (global clinical trial data sources, SDTM & ADaM, end-to-end clinical data design and analysis pipeline, clinical data security and governance). Experience in Agile product development as a participating member of a scrum team and related ceremonies and processes. Ability to collaborate with data scientists and data engineers to deliver functional business requirements as well as defining the product roadmap. High learning agility, demonstrated ability to quickly grasp ever-changing technology and clinical development domain knowledge and apply it to project work. Strong communication skills in writing, speaking, presenting, and time management skills. Preferred Qualifications Training or education degree in Computer Science, Biology, or Chemistry. Experience with Clinical Data and CDISC (SDTM and ADaM) standards . Soft Skills Excellent analytical and troubleshooting skills. Deep intellectual curiosity, particularly about data patterns, and learning about business processes and the life of the user. Highest degree of initiative and self-motivation. Strong verbal and written communication skills, including presentation to varied audiences through complex technical/business topics. Confidence in leading teams through prioritization and sequencing discussions, including managing collaborator expectations. Ability to work effectively with global, virtual teams, specifically including leveraging tools and artifacts to assure clear and efficient collaboration across time zones. Ability to manage multiple priorities successfully. Team-oriented, with a focus on achieving team goals. Strong problem-solving, analytical skills. Ability to learn quickly and retain and synthesize complex information from diverse sources.

Medical Writer II (CSR Narrative exp Only) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications - Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing - Good Experience of independent authoring and reviewing CSR Narratives only. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Medical Writer II (CTT) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Medical Writer II (Clinical Trial Transparency) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget. Performs on-line clinical literature searches, as applicable. Working knowledge of drug development process and regulatory guidelines. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership. Completes required administrated tasks within the specified timeframes. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Qualifications Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach. Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Education : UG: B Tech in Mechanical, BSc, B. Tech Medical Science, M sc. Key skills: Regulatory Submissions : 510(k), CE Marking, EU MDR 2017/745, US FDA, Indian MDR 2017 Clinical Evaluation Reports (CER) : Development, Literature Reviews, Clinical Data Analysis Risk Management : ISO 14971, Risk Assessments, Risk Mitigation Strategies Post Market Surveillance (PMS) : Data Collection, Reporting, Device Performance Monitoring Post Market Clinical Follow-up (PMCF) : Study Design, Data Analysis, Reporting Regulatory Compliance : US FDA, EU MDR, Indian MDR, ISO 13485 Communication : Cross-functional collaboration, technical writing, regulatory guidance Desired Candidate Profile: Regulatory Affairs Executive with 3-4 years of experience in medical device regulation and compliance. Proficient in preparing and submitting regulatory filings for product approvals, conducting clinical evaluations, managing risk assessments, and ensuring post-market compliance across multiple regions. Experienced in EU MDR 2017/745, US FDA regulations, Indian MDR 2017, and ISO 13485 standards. Proven ability to collaborate with cross-functional teams to meet regulatory requirements and deliver high-quality documentation, including Clinical Evaluation Reports (CER), Post Market Surveillance (PMS) reports, and PMCF studies. Company Profile: One of the Leading manufacturers and suppliers of Orthopedic Implants and instruments, founded in 1987 and having manufacturing unit at Rai Industrial Area, District Sonipat, Haryana and Corporate Office in Phool Bagh, Rampura, New Delhi Near Ashok Park Main Metro Station.

Sr Medical Writer (Redaction) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities - 1. Authoring andQuality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2. Additional Activities Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s) Qualifications - We are looking for 4-8 years experience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management. - Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected. Qualification Requirement - Educational qualifications: A minimum of a scientific graduate degree in life sciences. - Good knowledge of regulatory requirements or guidance pertinent to the service line. - Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills - Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required. - Person should understand & comprehend protocol and clinical study report from disclosure perspective. - Good understanding of clinical trial disclosure fundamental - Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working - Ability to build rapport/ relationships with project-specific client colleague Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Principal Medical Writer (CTT) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we re able to create a place where everyone feels like they belong. Job Responsibilities 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH, ,National registries (DIMDI)) - CTT Data base experience ( Disclose, Prime, PRS, EudraCT) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2. Additional Activities Completion of Internal and Client specific training. Assist in mentoring and training of team members depending upon project requirement(s) Qualifications We are looking for 8 years experience medical writer who will be involved in CTT/redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management. Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding of Clinical Trial Disclosure fundamentals is expected. Qualification Requirements - Educational qualifications: A minimum of a scientific graduate degree in life sciences. - Good knowledge of regulatory requirements or guidance pertinent to the service line. - Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills - Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required. Person should understand & comprehend protocol and clinical study report from disclosure perspective. - Good understanding of clinical trial disclosure fundamental - Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working Ability to build rapport/ relationships with project-specific client colleague Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Job Type- Fresher or Internship level Clinical Research Associates manage clinical trials and studies pertaining to biotechnological and pharmaceutical products, drugs and procedures. A Clinical Research Associate, also known as a CRA, conducts research to ensure these products are safe. Responsibilities: 1. Assist in Protocol Development: Collaborate with the clinical research team to contribute to the development and review of clinical trial protocols. 2. Site Identification and Selection: Participate in the process of identifying and selecting clinical trial sites by conducting feasibility assessments. 3. Regulatory Compliance: Support the team in ensuring regulatory compliance throughout the clinical trial process. Assist in the preparation and submission of regulatory documents to appropriate health authorities. 4. Site Initiation: Assist in the initiation of clinical trial sites by coordinating site training activities and ensuring that all necessary documentation is in place. 5. Monitoring and Data Collection: Work closely with clinical research associates and investigators to monitor and collect data during the clinical trial. Assist in ensuring data accuracy, completeness, and adherence to protocol. 6. Adverse Event Reporting: Contribute to the process of monitoring and reporting adverse events, ensuring compliance with regulatory requirements. 7. Study Close-Out: Participate in the close-out activities of clinical trials, including the collection of essential documents and finalizing study reports. 8. Collaboration and Communication: Work collaboratively with cross-functional teams, including clinical operations, data management, and regulatory affairs. Communicate effectively with investigators, site staff, and study sponsors. 9. Documentation and Record Keeping: Maintain accurate and up-to-date documentation of all activities performed during the internship. Contribute to the development and organization of the trial master file. 10. Learning and Development: Actively engage in learning opportunities provided during the internship to enhance knowledge of clinical research processes and industry regulations. Qualifications: Currently enrolled in a Bachelor's or Master's degree program in a related field (e.g., Life Sciences, Pharmacy, Nursing, etc.). Excellent communication and interpersonal skills. Detail-oriented with strong organizational and time management abilities. Ability to work independently and as part of a team.