135 Clinical Data Jobs

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.

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.

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 Create SAS programs to generate derived analysis datasets and content for tables, listings, and figures; Perform programming validation to ensure quality of analysis datasets and programming outputs Support the electronic submission preparation and review Reviews key planning documents (e. g. , statistical analysis plan, data presentation plan, data review plan) to ensure alignment with development team objectives and clarity and completeness of programming assumptions and requirements; Assesses impact on programming activities Interacts with vendors regarding project standards, programming conventions, programming specifications and file transfers Provides leadership for ensuring quality of Global Biometric and Data Sciences (GBDS) deliverables by consistently applying standards and complying with regulatory requirements, guidance and corporate and departmental SOPs and work practices Identifies opportunities for increased efficiency and consistency within GBDS and our interactions with strategic vendors Independently leads and / or performs programming assignments across multiple projects with minimal supervision Support improvement initiatives Skills, knowledge, and experience 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. Exposure or have working experience on real-world data or real-world evidence 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 or solid knowledge in other software, such as R/R-Shiny 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.

Job Description Summary As part of the Science and Technology Organization, we develop the services that drive the next generation of healthcare applications and enable developers to build new and innovative solutions that seamlessly span clinical devices & sensors, local compute and storage hubs, and a global footprint of cloud resources. We are looking for a talented and creative expert to accelerate the development of cloud-first, AI-enabled healthcare solutions by building reusable services. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Work backwards from customers to define the strategy for one of our cloud-first services. Identify target user personas and markets for integration of applications and AI into customer workflows. Clearly articulate value-propositions to drive adoption and relevance. Build cost/pricing models, partner vs build vs buy strategy. Work closely with customers, architects, engineers, and external vendors to prioritize deliverables and ensure releases meet roadmap content and timelines. Work with cross-functional teams to innovate and change the way software is deployed and commercialized to rapidly bring to market new solutions that help unlock, correlate, and analyze the clinical data that powers todays intelligent, precision healthcare. Be equally comfortable digging into business and commercial requirements and digging into operational and deployment strategies with service, architecture and design teams Be flexible, excel when faced with ambiguity and thrive in a fast-paced environment. Have a bias for acting now - then iterate. Required Qualifications Bachelors degree in Engineering, Computer Science or related field with 15+ years of managing and/or activating products in a related industry including hands-on management of large, cross-functional software and system efforts Proven experience in identifying customer s business and strategic needs, concerns, and desires to drive value-adding product capabilities Desired Characteristics Master s Degree in Engineering, Computer Science or related field 3+ years of hands-on software engineering experience Experience leading and/or managing efforts in a distributed systems environment Hands-on experience with Service-Oriented Architecture (SOA) and Cloud solutions Familiarity with Healthcare workflows and deployment scenarios Real world experience with portfolio and investment decisions to balance customer needs, existing product requirements and long term enterprise differentiation Strong written and verbal communication skills Ability to excel in a fast-paced, startup-like environment GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration and support. #LI-RS1 #Hybrid Relocation Assistance Provided: Yes

Project entitled :- Investigating the clinical relevance of environmental chemicals and exosomal miRNA biomarkers in the pathophysiology of Polycystic Ovary Syndrome funded by Indian Council of Medical Research. Name of the Post :- Project Research Scientist-I (Medical) No. of vacancy :- One Consolidated Salary :- Rs.87,100/- (Rs.67,000/- plus 30% HRA) Essential Qualification Desirable / Job Responsibilities :- MBBS / BVSc / BDS or equivalent. Desirable Qualification / Job Responsibilities :- Research experience in clinical studies. Experience in writing reports/manuscripts He/she will be looking after overall implementation of the project. He/she will be engaged in screening of the participants, filling case record forms, supervising appropriateness of blood collection and data entry. He/she will prepare the report of the project time to time. Age Limit :- 35yrs Duration / Tenure :- Up to 31.01.2026 (extendable up to 31.01.2027) Interested Candidates can share their cv on this mail id anchal.g@esolglobal.com.

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Quality Audit Coordinator serves as the central point for all sponsor, regulatory, supplier, and internal audits across the company s eClinical solutions. The role safeguards continuous inspection readiness by organizing evidence, managing logistics before, during, and after each audit, and collaborating with departments across the entire Organization. Success is measured by complete and accurate audit files, on-time CAPA closure, and ongoing process improvements that streamline future inspections. KEY TASKS & RESPONSIBILITIES Pre-audit coordination assists with scheduling audits, confirm audit scope, assembles document packages, schedule interviews with subject-matter experts, and prepare on-site or virtual audit rooms. Live audit support serve as primary scribe, manage real-time document requests, track question/response logs, and controls the flow of materials to auditors. Post-audit follow-up compile meeting minutes, distribute observation summaries, assists in maintaining a findings tracker, and coordinate timely CAPA responses with owners. Maintain audit documentation keep electronic folders and QMS trackers current, version-controlled, and compliant with retention requirements. Support internal quality audits schedule, prepare, and close routine internal audits. Capture and verify records document audit interviews accurately and circulate for stakeholder confirmation. Facilitate cross-functional readiness ensure the various business units have evidence and answers prepared in advance. Assist with vendor audits assist with coordinating assessments of third-party eClinical service providers and monitor follow-up actions. Improve audit processes recommend and implement tools or workflow changes that reduce audit-prep time and strengthen documentation integrity. Update SOPs and work instructions related to audit management and inspection readiness. Perform additional duties as assigned to enhance the Quality Management System and maintain continuous inspection readiness. Education & Experience Bachelor s degree in a related field is preferred 3-5 years of experience working in a pharmaceutical industry is preferred. Knowledge of clinical trial terminology and process. Knowledge of GxP quality standards, applicable regulations, and software development risks. Professional Skills Professionalism, confidentiality, and organization. Excellent writing and typing skills. High level of organizational skills and record-keeping. Ability to work effectively under critical deadlines. Robust communication skills and attention to detail. Technical Skills Ability to pull reports or extract data when needed. Ability to easily learn various software applications. Experience with Qualio or other type of QMS tool Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (eg, coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients Medical terminology exposure Excellent organizational, communication, leadership and computer skills Ability to exercise excellent attention to detail Ability to act independently and with initiative required to resolving problems Ability to establish and maintain effective working relationships with coworkers, managers and clients

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. OVERVIEW The Compliance Associate will assist the Sr. Compliance Manager with relevant laws, regulations, and internal policies. Responsibilities will also include managing the Vendor Intake process, conducting vendor audits, and guiding other department personnel thru the vendor management process. KEY TASKS & RESPONSIBILITIES Assist the Sr. Compliance Manager with key compliance-related initiatives such as SOC2, ISO, and other related areas. Manage the Vendor Intake process by working with departmental leaders to assess / re-assess vendors as required. Provide backup support as required to the overall Quality and Compliance team. Respond to co-worker questions regarding compliance regulations and industry best practices. Represent Vendor Management in Audits and ongoing process improvements. Serve as a document coordinator owning the maintenance of Compliance documentation -SOP, WIs, Templates, Forms, ensuring content accuracy and adherence to standards. Other duties as assigned Education & Experience BS degree or job-related equivalency preferred Experience in Quality and Compliance, or similar administrative role Experience and knowledge of compliance regulations and industry best practices Experience working in a fast-paced environment preferred Professional Skills Excellent knowledge of English Strong understanding of business goals and standards for customer service Strong Presentation skills Excellent decision-making skills Strong interpersonal and communication skills Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company. Technical Skills Strong time-management and organizational skills Problem-solving skills Analytical skills Adaptable to change Attention to detail Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours! eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here! We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full 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 statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs 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, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide 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. En-sure 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 and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program 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 contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at 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 the acceptance within and out-side the organization, of innovative methods, 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, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team 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 modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in 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. Good business ethics Commitment to Diversity and Inclusion: Accessibility and accommodation Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Job Overview Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager. Essential Functions Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that dont require extensive programming expertise) with guidance. May serve in the role of back-up to a DOC or DTL. May conduct data review. May write and resolve data clarifications. May lead database audit team. May develop and test databases and edit specifications. May perform testing of programming. May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team." Qualifications Bachelors Degree Clinical, biological or mathematical sciences, or related field Req Equivalent combination of education, training and experience in lieu of degree. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. Medical terminology exposure. Excellent organizational, communication, leadership and computer skills. Ability to exercise excellent attention to detail. Ability to act independently and with initiative required to resolving problems. Ability to establish and maintain effective working relationships with coworkers, managers and clients. . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide . Learn more at https://jobs.iqvia.com

Assistant Professor (Biosciences) Academic Level 12 Sri Sathya Sai Institute of Higher Learning (SSSIHL) Assistant Professor (Biosciences) Academic Level 12 Department of Biosciences, Anantapur Campus SSSIHL/24-25/Biosci/ACA/046 Full-time (Women applicants) Salary: Basic: 79,800 + Dearness Allowance (DA) & House Rent Allowance (HRA) as per Institute rules Higher qualifications and relevant experience will be considered ESSENTIAL QUALIFICATIONS & EXPERIENCE Ph.D. in Biosciences or any related areas Master s degree in Biosciences or any related areas with a Bachelor s degree in Biosciences or any related areas Good academic performance in relevant fields from a recognized University/Institute Desirable to have cleared UGC NET/CSIR NET/SLET/SET (unless exempted as per UGC regulations for Ph.D. holders) At least 4-5 years of Post PhD experience Ability to introduce and establish cutting edge research in AMR community outreach and epidemiology, or Disease biology experience working with patient samples and data, Multimodal Imaging, Multi-omics in particular working with genomics, Drug discovery/bioinformatics, etc. or working with cell-based techniques for therapy/regenerative medicine, 3D cell culture for drug screening, experience with 3D printing, molecular biology and strain development for recombinant protein expression in bacterial / yeast / insect / mammalian cell culture. Working with community outreach will be a plus with high impact publications Working with more than one of the techniques like clinical data accession or model systems or integrated omic analysis or multimodal imaging or 3D printing and 3D cell culture will be a plus Experience in establishing labs and track record of getting extramural funding Research-oriented mindset with a focus on academic excellence Ability to integrate modern learning tools and research methodologies Proficiency in English and ability to mentor students effectively Commitment to SSSIHL s code of conduct and values-based integral education system KEY RESPONSIBILITIES Teaching and Academic Leadership Introduce new specialization Syllabus design Coaching students for National level exams Enable experiential learning Research and Innovation High impact publications Guiding BS, MSc, MS and PhD Students Guiding internships Raising grants and consultancies Establishment of Research and teaching facilities in field of specialization Student Engagement and Mentorship STEP 2 Attach your detailed resume (must include details of Ph.D. qualification, NET/SLET/SET or other national level exams passed, teaching/professional experience, roles, and responsibilities in chronological order, list of research publications published in reputed UGC CARE journals and conference presentations & proceedings, list of research projects, significant achievements/recognitions, post-docs and research students guided, Areas of expertise and courses taught at UG/PG level, and at least two references (academic and/or professional) STEP 3 Scanned copies of all certificates/documents related to your educational qualifications and professional experience Applicants desiring to apply for more than one position should submit separate applications for each. SSSIHL reserves the right to reject application forms that are incomplete and not as per specified requirements. SSSIHL reserves the right to call only the requisite number of candidates for an in-person demo and/or interview after shortlisting based on the candidate s suitability for the vacant position. There will be no personal communication with candidates other than those shortlisted for the interview. All applicants are required to ensure that all the information submitted (Resume, Annexure form,and documents) is accurate and correct for scrutiny If any application is found to contain information that is inaccurate or false either during the employment process or after the appointment of the candidate, SSSIHL reserves the right to reject the application at any stage or take stringent action on the employee as deemed suitable.

Hi We are hiring for Leading ITES Company for Clinical Data Manager Profile. Role & responsibilities: Candidate should have 2-5 years of experience of CDM with experience in Conduct Scope of work Perform day-to-day Clinical Data Management activities. Experience in doing external data reconciliation Work and coordinate with the team to perform data management activities and deliver an error-free quality database in accordance with the data management plan and regulator standards. Read and understand the study protocol and the timelines. Perform test data entry in the TEST environment, data listing review, data reconciliation, and query management tasks. Escalate/Action discrepancy in the clinical data as appropriate. Perform external checks to handle manual discrepancies and action the same. Ensure an error-free, quality data with no open queries. Escalate any discrepancy in the clinical data to the study lead as appropriate. Timely completion of training Any other tasks deemed appropriate To perform medical data collection and analysis of Prostate Cancer Data using databases like HIS/ EMR (Electronic Medical Record) and Caisis, Rave, CDM (startup, closeout, conduct) Client interaction and meetings. Bringing up new ideas and executing new plans to cope with the backlog. Training new team members as and when required. To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 205 b) To Apply for above Job Role ( Pune ) Type : Job Code # 206 c) To Apply for above Job Role ( Bangalore ) Type : Job Code # 207

Job Title: Associate Global Development Scientist Director, Late Development Oncology Global Career Level: E Introduction to role: Are you ready to make a difference in the world of oncology? The Global Development Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. The Global Development Scientist and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies. This includes providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). The Global Development Scientist may also provide expert input or lead functional process improvement initiatives and provide contributions to cross asset or cross tumor area working groups depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Accountabilities: Clinical Development Responsibilities - Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions. - Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross-functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites. Serves as contact with vendors and CROs regarding medical/clinical science issues. - Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc., and write any necessary queries to be communicated to sites to ensure data accuracy and completeness of the assigned study. - Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information are shared with cross-functional study team. Support review of safety narratives. - Supports preparation of abstracts, manuscripts, publications, and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities. - Assists with drafting assigned sections of clinical reports, dossiers, and other documents. - Support Data Management in the build of the CRF and all associated instructions and plans (e.g., CRF completion instructions and Data Review Plan). Technical Skills - Basic understanding of drug development from molecule to market and demonstrates knowledge of scientific methodology in the design, conduct, and description of clinical research at a study level. - Ability to understand and contribute to the drafting of documents used throughout the clinical study lifecycle, such as site initiation materials, registration documents, protocols, and presentations. Demonstrates solid understanding of methodology in the design, conduct, and interpretation of clinical research. Outstanding attention to detail and outstanding written communication skills. - Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deliverables during study life cycle (e.g., the protocol, CRF, data listings, TLF, CSR etc.) - Ability to analyze and summarize clinical results. Support creation of and review of clinical slides for internal and external meetings. Essential Skills/Experience: - Required Life Sciences degree or equivalent - PharmD, Ph.D. degree in life sciences, or MD preferred. Strong preference for Oncology experience - Industry or academic experience in drug development required. - Possesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research. - Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals. - Ability to grow and maintain a high level of expertise in oncology therapeutic area. At AstraZeneca, we are driven by a mission to transform cancer treatment through innovative approaches like novel biomarkers, AI, novel endpoints, and cutting-edge trial designs. Our collaborative environment empowers you to take smart risks and challenge norms while working alongside top experts globally. With one of the broadest oncology pipelines in the industry, youll have opportunities to work with new drugs that truly improve patient outcomes. Ready to join us on this exciting journey? Apply now to be part of our transformative team! 12-Jun-2025 17-Jun-2025

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description: Principal Responsibilities: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Clinical Programmer: Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio and Study Leads for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor s degree or higher and/or equivalent in computer science, mathematics, data science/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience and Skills Required: Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills.

Job Summary: We are seeking a highly skilled Lead Data Engineer/Associate Architect to lead the design, implementation, and optimization of scalable data architectures. The ideal candidate will have a deep understanding of data modeling, ETL processes, cloud data solutions, and big data technologies. You will work closely with cross-functional teams to build robust, high-performance data pipelines and infrastructure to enable data-driven decision-making. Experience: 7 - 12 years Work Location: Hyderabad (Hybrid) / Remote Mandatory skills: AWS, Python, SQL, Airflow, DBT Must have done 1 or 2 projects in Clinical Domain/Clinical Industry. Responsibilities: Design and develop scalable and resilient data architectures that support business needs, analytics, and AI/ML workloads. Data Pipeline Development: Design and implement robust ETL/ELT processes to ensure efficient data ingestion, transformation, and storage. Big Data & Cloud Solutions: Architect data solutions using cloud platforms like AWS, Azure, or GCP, leveraging services such as Snowflake, Redshift, BigQuery, and Databricks. Database Optimization: Ensure performance tuning, indexing strategies, and query optimization for relational and NoSQL databases. Data Governance & Security: Implement best practices for data quality, metadata management, compliance (GDPR, CCPA), and security. Collaboration & Leadership: Work closely with data engineers, analysts, and business stakeholders to translate business requirements into scalable solutions. Technology Evaluation: Stay updated with emerging trends, assess new tools and frameworks, and drive innovation in data engineering. Required Skills: Education: Bachelor's or master's degree in computer science, Data Engineering, or a related field. Experience: 7 - 12+ years of experience in data engineering Cloud Platforms: Strong expertise in AWS data services. Databases: Hands-on experience with SQL, NoSQL, and columnar databases such as PostgreSQL, MongoDB, Cassandra, and Snowflake. Programming: Proficiency in Python, Scala, or Java for data processing and automation. ETL Tools: Experience with tools like Apache Airflow, Talend, DBT, or Informatica. Machine Learning & AI Integration (Preferred): Understanding of how to architect data solutions for AI/ML applications

DeepIntent is leading the healthcare advertising industry with data-driven solutions built for the future. From day one, our mission has been to improve patient outcomes through the artful use of advertising, data science, and real-world clinical data. For more information visit, www.DeepIntent.com or find us on LinkedIn. What You ll Do: DeepIntent is seeking a Sr. Talent Partner to join our growing team based in our Pune, India office. In this role, you will support a wide breath of positions across different departments at DeepIntent. You must have experience sourcing and full cycle recruiting for roles across finance, client services, platform operations, marketing, engineering and product. We are looking for an experienced Sr. Talent Partner who has managed full-cycle recruiting and has experience across all facets of the recruiting and hiring process. From sourcing and screening candidates, partnering with hiring managers on hiring strategy, through to offer and negotiations. Due to the partnership nature of this position, you will facilitate and lead meetings with hiring teams to establish and maintain meaningful relationships with hiring teams, interviewers, senior leadership and key cross-functional stakeholders. Manage the full-cycle recruiting process, from initial strategy meetings with hiring managers, to sourcing/screening, facilitating offers and closing candidates Proactively source candidates (active and passive) through referrals, networking and innovative research tactics Create a plan to increase workforce diversity and continue to foster DeepIntent s culture of inclusion Ensure operational excellence, focusing on quality, customer experience and process efficiency Partner with hiring managers, interviewing teams, and senior leadership on hiring initiatives Oversee and manage a detail-oriented and organized process, providing an exceptional candidate experience Effectively communicate and negotiate all parts of an offer package (base, bonus, equity) Establish a partnership and build trust with hiring teams and stakeholders while being the expert in Talent Acquisition Who You Are: 5+ years of experience managing full-cycle recruitment A strong understanding of the digital advertising/adtech landscape Strong verbal and written communication skills; confident in communicating with stakeholders across the organization Experience working for a fast-paced, tech startup and partnering with senior leadership on hiring initiatives Ability to proactively source top talent, gain candidate interest and pitch candidates on DeepIntent s mission, values and goals Ability to negotiate compensation packages and close candidates Working knowledge of Greenhouse strongly preferred We believe great work starts with great support. That s why DeepIntent offers a competitive, holistic benefits package designed to empower you both professionally and personally. Here s what you can expect when you join our team: Competitive base salary plus performance based bonus or commission, comprehensive medical, dental, and vision coverage, 401K match program, generous PTO policy and paid holidays, remote friendly culture with flexible work options, career development and advanced education support, WFH and internet stipends, plus many more perks and benefits! DeepIntent is committed to bringing together individuals from different backgrounds and perspectives. We strive to create an inclusive environment where everyone can thrive, feel a sense of belonging, and do great work together. DeepIntent s commitment to providing equal employment opportunities extends to all aspects of employment, including job assignment, compensation, discipline and access to benefits and training.

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry