1120 Clinical Research Jobs

Note: This role would involve Rotational Shifts (Morning and Nights) Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeon/Consultant Roles and Responsibilities Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeons

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Knowledge and Experience: • Minimum of 2 years experience in quality assurance, auditing, including sound experience of applicable GxP auditing • At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research Education: • Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience • Master’s degree in a science, technology or industry related discipline, preferred

PMS College of Dental Sciences & Research is looking for Asst Proffesor - Pharmacology to join our dynamic team and embark on a rewarding career journey Develop and deliver high-quality lectures and instructional materials. Conduct research and publish findings in academic journals. Advise and mentor students on academic and career matters. Participate in academic committees and contribute to curriculum development. Stay current with developments in the field and incorporate them into teaching.

Lilavati Medical Center is looking for Clinical Associate - Radiology to join our dynamic team and embark on a rewarding career journey Perform and interpret diagnostic imaging procedures, including X-rays, MRI, CT scans, and ultrasounds. Provide expert consultation to other physicians regarding radiologic findings. Ensure high-quality imaging and patient safety. Stay updated with advancements in radiology technology and techniques. Participate in multidisciplinary team meetings to discuss patient care plans. Conduct research and contribute to radiology publications. MD/DNB (Radiology) with post graduate experience from a reputed Hospital.

Fever99 healthcare is looking for Psychologist to join our dynamic team and embark on a rewarding career journey Conduct comprehensive psychological evaluations to assess patients' mental health and emotional status. Diagnose and treat patients with a range of mental health and emotional disorders, including anxiety, depression, bipolar disorder, and schizophrenia. Develop and implement treatment plans that are tailored to each patient's unique needs, and that incorporate evidence-based interventions and therapies. Provide individual and group therapy, using a variety of therapeutic approaches, such as cognitive-behavioral therapy, psychoanalytic therapy, and humanistic therapy. Collaborate with other healthcare professionals, such as psychiatrists, social workers, and primary care physicians, to ensure coordinated and comprehensive patient care. Monitor patient progress, and adjust treatment plans as needed to ensure that patients are receiving effective and appropriate care. Maintain accurate and complete patient records, and comply with legal and ethical standards related to patient confidentiality and privacy. Provide education and support to patients and their families, and help them develop coping skills and strategies for managing their mental health and emotional well-being.

Adani Hospitals is looking for Medical Officer to join our dynamic team and embark on a rewarding career journey Diagnosing and treating patients' illnesses and injuries Creating and maintaining patient medical records Prescribing medication and therapies Ordering and interpreting diagnostic tests Referring patients to specialists as needed Developing and implementing treatment plans Educating patients about their health conditions and treatment options Working closely with patients and their families, as well as other healthcare professionals Clinical Medical Officer MBBS

Althera Laboratories India private Limited is a leading OSD (Oral Solid Dosage) manufacturing company committed to developing and delivering innovative pharmaceutical products. We are seeking a highly motivated and experienced Clinical Project Manager to lead and oversee clinical trials for our drug development pipeline. Role & responsibilities Develop and execute comprehensive clinical project plans, timelines, and budgets in alignment with company objectives and regulatory requirements. Oversee all aspects of clinical trial conduct, including protocol development, site selection, investigator initiation, patient recruitment, data management, and safety monitoring. Prepare and present clinical study reports, regulatory submissions, and other relevant documentation. Ensure adherence to Good Clinical Practice (GCP) guidelines, ICH regulations, and other relevant regulatory standards. Collaborate effectively with cross-functional teams, including R&D, regulatory affairs, quality assurance, and medical affairs, to achieve project milestones. Build and maintain strong relationships with key stakeholders, including investigators, CROs, and regulatory authorities. Monitor and manage project timelines, budgets, and resources effectively. Identify and mitigate project risks proactively. Proficiency in clinical trial management software and systems. Required Qualifications: M. Pharma/Ph.D Min. 8 to 12 years of experience in clinical project management within the pharmaceutical industry. In-depth knowledge of EU regulatory requirements for drug development and clinical trials Strong understanding of clinical research methodologies and statistical principles. Proactively manage project risks, develop mitigation strategies, and communicate effectively to project teams and management. Strong leadership and interpersonal skills with the ability to build and motivate cross-functional teams. Preferred Qualifications: - Experience in OSD product development and clinical trials. Knowledge of global regulatory requirements.

As a Therapy Lead in our Medical Affairs function, you'll be at the forefront of shaping and executing the medical strategy and scientific engagement activities for your assigned therapeutic area or region. You'll oversee the delivery of crucial scientific support to our marketing and brand management teams, cultivate strong relationships with Key Opinion Leaders (KOLs), and champion impactful medico-marketing initiatives. This pivotal leadership role requires you to align medical strategy with business goals, all while ensuring medico-marketing activities support product promotion in line with ethical practices. Key Responsibilities Leadership & Strategic Oversight : Provide strategic direction and leadership for the medical affairs activities within your assigned therapeutic area or region. Scientific Support for Marketing & Brand Management : Offer robust scientific support, insights, and guidance to commercial teams, ensuring accuracy and scientific integrity in promotional materials and strategies. KOL Engagement & Scientific Relationship Building : Develop and nurture strong, collaborative relationships with Key Opinion Leaders and other scientific experts to foster scientific exchange and gather insights. Medico-Marketing & Scientific Communication : Drive the development and execution of medico-marketing initiatives and scientific communication plans, including publications, presentations, and educational programs. Clinical Research & Real-World Evidence (RWE) Generation : Contribute to the design and interpretation of clinical research and real-world evidence generation activities to support product value propositions. Regulatory & Compliance Leadership : Ensure all medical affairs activities adhere to relevant regulatory guidelines, industry codes, and ethical standards. Key Qualifications Education: MD, MBBS is required. An MBA or additional management qualifications will be an advantage. Experience: 7 - 10 years of experience in Medical Affairs , with at least 5 years in a leadership role . Extensive experience in providing scientific support to commercial functions , leading medico-marketing activities , and managing KOL relationships . Proven track record of developing and implementing medical strategies aligned with business objectives in the pharmaceutical industry . Therapeutic Area Expertise : Prior experience in managing medical affairs in key therapeutic areas such as Dermatology, Endocrinology, Cardiology, Gastroenterology , etc.

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.

Sr Biostatistician Job Responsibilities Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR. Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, and figures. Collaborate with the sponsor, if required. May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report. Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department. Creates or reviews programming specifications for analysis datasets, tables, listings, and figures. Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis. Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications. Implements company objectives, and create alternative solutions to address business and operational challenges. Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines. Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management. Provides statistical programming support as needed. May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician. May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness. Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business. Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defense meetings. Coaches and mentors other Biostatistics staff. Performs other work-related duties as assigned. Minimal travel may be required. Qualifications Graduate degree in biostatistics or related discipline. Moderate experience in clinical trials or an equivalent combination of education and experience. Proficiency in programming. Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts. Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English.

The selected candidate will primarily work on Databricks and Reltio projects, focusing on data integration and transformation tasks. This role requires a deep understanding of Databricks, ETL tools, and data warehousing/data lake concepts. Experience in the life sciences domain is preferred. Candidate with Databricks certification is preferred. Key Responsibilities: Design, develop, and maintain data integration solutions using Databricks. Collaborate with cross-functional teams to understand data requirements and deliver efficient data solutions. Implement ETL processes to extract, transform, and load data from various sources into data warehouses/data lakes. Optimize and troubleshoot Databricks workflows and performance issues. Ensure data quality and integrity throughout the data lifecycle. Provide technical guidance and mentorship to junior developers. Stay updated with the latest industry trends and best practices in data integration and Databricks. Required Qualifications: Bachelor s degree in computer science or equivalent. Minimum of 5 years of hands-on experience with Databricks. Strong knowledge of any ETL tool (e.g., Informatica, Talend, SSIS). Well-versed in data warehousing and data lake concepts. Proficient in SQL and Python for data manipulation and analysis. Experience with cloud platforms (e.g., AWS, Azure, GCP) and their data services. Excellent problem-solving skills. Strong communication and collaboration skills. Preferred Qualifications: Certified Databricks Engineer. Experience in the life sciences domain. Familiarity with Reltio or similar MDM (Master Data Management) tools. Experience with data governance and data security best practices. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. 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 Save this job LEARN ABOUT HOW WE WORK Join our Global Talent Network Let s stay connected. Sign up to receive alerts when new opportunities become available that match your career ambitions.

Principal Stat Programmer (ADAM + TFL) Job Responsibilities - The ideal candidate will have extensive experience in statistical programming above 5 plus years within clinical research, specifically in supporting Phase 2 and Phase 3 studies. This role involves leading programming activities, overseeing project deliverables, and ensuring compliance with regulatory standards and timelines. Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well asany regulatory required documents. (i.e. DEFINE.XML) When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. Transfers deliverables. Performs other work-related duties as assigned. Minimal travel may be required Qualifications Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. Experience in mentoring others in clinical trial process and CDISC Standards. Excellent written and verbal communication skills. Ability to read, write, speak and understand English.

Manager, Safety & PV (Japanese Language Professional) 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 Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization. Assigns project work and reviews workload for all direct reports. Provides oversight and guidance on organizational goals and company objectives. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management. Manages projects where Safety and Pharmacovigilance are the primary services. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues. Participates in the management of the Safetyand Pharmacovigilance department with the following actions: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings. Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Participates in bid defense meetings. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project. Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process. Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members Managing resourcings needs/issues and escalating to senior management as necessary. Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions. Performs other work related duties as assigned. Minimal travel may be required. Qualifications - Must be a N3 or above certified (JLPT) Japanese Language professional - BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience Progressive responsibility with demonstrated leadership skills and project management Clinical Research Organization (CRO) experience with therapeutic specialties preferred Working knowledge of financial budgets and various financial analysis tools preferred Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills Ability to establish effective relationships with clients as well as team members Ability to be flexible, adapt to change, work independently, as well as part of a teamin a matrix environment Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment 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.

The Clinical Data Coordinator (Intern/Fresher Level) plays a crucial role in ensuring the integrity and quality of clinical trial data. This position offers a valuable entry point into the field, providing hands-on experience in core data management tasks and industry best practices. Key Responsibilities: Data Entry and Verification: Meticulous data entry into electronic data capture (EDC) systems. Verify data accuracy and consistency against source documents (e.g., Case Report Forms). Learn to identify and flag potential data discrepancies. Query Generation and Resolution: Develop an understanding of data discrepancies and their underlying causes. Assist in generating data queries to clarify issues with clinical sites. Track and follow up on resolution of data queries. Database Maintenance: Participate in database lock and maintenance procedures under supervision. Assist in implementing changes or updates to the EDC system. Reports and Metrics: Learn to generate basic data cleaning reports. Gain exposure to data quality metrics and key performance indicators. Process Improvement: Actively contribute ideas to streamline data cleaning and review processes. Qualifications: Fresher Recent graduate with a degree in life sciences, statistics, computer science, health informatics, or a related field. Intern: Currently enrolled in a relevant degree program in the fields mentioned above. Exceptional attention to detail and commitment to accuracy. Basic proficiency in Microsoft Excel. Strong interest in data management and clinical research. Desired Skills: Prior experience in a healthcare or research setting. Familiarity with medical terminology. Exposure to clinical database systems (EDC). Knowledge of Good Clinical Practice (GCP) guidelines (training will be provided). What You'll Gain: In-depth understanding of clinical data flow and data cleaning processes. Proficiency in using electronic data capture (EDC) systems. Experience with data quality review and query management. Appreciation for regulatory requirements in clinical data management. Mentorship from experienced data management professionals.

We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing, MBBS Background: Life Sciences or Healthcare domain Experience: 02 years Location: Open to all Indian cities (program delivered online & offline) Must have interest in Clinical Trials, Research, Pharmacovigilance, or Regulatory Affairs

Job description Brief Job Description - Analysts conduct desk-based research (incl. clinical, scientific, regulatory, commercial, etc.) on high-importance topics and generate reports which incorporate critical and analytical thinking. They are expected to keep abreast of developments in their assigned therapeutic area/s and continuously assess the impact of any new events/findings. They should have been involved in client interactions, mentoring, travel to healthcare/pharmaceuticals conferences and project planning. Candidate - Highly enthusiastic and committed individuals with strong analytical, project planning and client facing skills are sought for this position Knowledge of at least one of the following areas - Neurology, Oncology, Immunology, Psychiatry, Hematology, Endocrinology, Ophthalmology, Rare diseases, Biosimilars and Generics Candidates are expected to be meticulous, thorough and well organized. They should be quick learners, have an excellent work ethic and should be willing and able to work in a rapidly evolving role/environment Candidates are expected to possess excellent communication skills, both written and oral The position offers a rare opportunity to be mentored by seasoned industry professionals within Vyuhgenics. For promising candidates, who display excellent analytical mindset, growth to senior analyst could be a prospect Responsibilities - This is a full-time, desk-based, job at our office in Bangalore, India The primary focus will be on creating well structured reports, containing in-depth analysis and accurate facts. They will also be expected to take a lead role in collecting scientific, clinical, regulatory and commercial evidence about therapeutic areas, products, markets, companies and customers of relevance to the global biopharmaceutical industry Travel to scientific and clinical symposia and conferences will be necessary Additional skills - Excellent English language skills and working knowledge of MS Office (Word, Excel, PowerPoint) or Google Docs.

Possess excellent medical knowledge, including a strong grasp of medical terminologies and complex disease conditions. Display a keen analytical mindset, enabling you to process and extract key information from medical records. Call 9318431991 Required Candidate profile Graduate or Post Graduate in Bachelor in Physiotherapy BPT, BDS , BHMS, or B. Pharma 2-4 years in medical records underwriter Rotational Shift, WFO Noida Location info.aspiringmantra@gmail.com

Job Description: The Clinical Pharmacist at Manipal Hospitals will be responsible for optimizing patient medication therapy to ensure safe and effective pharmaceutical care. The role includes conducting medication reviews, collaborating with healthcare professionals to develop therapeutic plans, and ensuring adherence to clinical guidelines and policies. The Clinical Pharmacist will also provide pharmacotherapy consultations, educate patients and healthcare staff regarding medication use, and participate in clinical rounds to monitor patient progress. Roles and Responsibilities Key Responsibilities: - Review and interpret medication orders to ensure appropriateness, safety, and efficacy. - Collaborate with physicians, nurses, and other healthcare professionals to develop and manage pharmaceutical care plans. - Conduct medication reconciliation and provide education to patients regarding their medications. - Monitor and evaluate patients for drug therapy outcomes, side effects, and drug interactions. - Participate in clinical rounds and provide input on medication-related issues. - Develop and implement policies and procedures relating to medication management. - Provide training and guidance to pharmacy staff and other healthcare professionals. - Stay updated with the latest research and developments in pharmacotherapy.

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, Hyderabad, Andhra Pradesh, India, Mumbai, India Job Description: Principal Clinical Programming Lead Position Summary: The Principal Programming Lead is a highly skilled Programmer with expert knowledge of programming languages, tools, and complex data structures, industry standards. The position requires proven technical and analytic abilities and strong capabilities in leading activities and programming teams in accordance with departmental processes and procedures. As a highly experienced Principal Programming Lead, they apply expert technical, scientific, problem-solving skills providing innovative and forward-thinking solutions to ensure operational efficiency across assigned projects providing training, coaching, mentoring to other programmers. The Principal Programming Lead position is accountable for the planning, oversight, and delivery of programming activities in support of one or more clinical projects, compounds, or submissions of high complexity and criticality. In this role, the Principal Programming Lead is responsible for making decisions and recommendations that impact the efficiency, timeliness, and quality of deliverables with a high degree of autonomy and provide leadership, direction and technical and project specific guidance to programming teams. In addition, this position may lead and contribute expert knowledge and technical skills to assigned delivery unit, departmental innovation, and process improvement projects. Principal Responsibilities: Designs and develops efficient programs and technical solutions in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis requests. Provides technical and project specific guidance to programming team members to ensure high quality and on-time deliverables in compliance with departmental processes. Coordinates and oversees programming team activities and may provide matrix leadership to one or more programming teams as needed. Shares knowledge and provides guidance and coaching to programmers in developing advanced technical and analytical abilities. Performs comprehensive review of, and provides input into, project requirements and documentation. Collaborates effectively with programming and cross-functional team members and counterparts to achieve project goals and independently manages escalations. As applicable, oversees programming activities outsourced to third party vendors adopting appropriate processes and best practices to ensure their performance meets the agreed upon scope, timelines, and quality. Responsible for adoption of new processes & technology on assigned projects/programs in collaboration with departmental technical groups and programming portfolio leads Oversees the design, development, validation, management, and maintenance of clinical databases according to established standards. Responsible for implementation of data tabulation standards. Performs data cleaning by programming edit checks and data review listings and Data reporting by creating data visualizations and listings for medical monitoring and central monitoring. Education and Experience Requirements: Bachelors degree (e.g., BS, BA) or equivalent professional experience is required, preferably in Computer Sciences, Mathematics, Data Science/Engineering, Public Health, or another relevant scientific field (or equivalent theoretical/technical depth). Advanced degrees preferred (e.g., Master, PhD). Experience and Skills Required: Approx. 10 -12+ years of experience in Pharmaceutical, CRO or Biotech industry or related field or industry. In-depth knowledge of programming practices (including tools and processes). Working knowledge of relevant regulatory guidelines (e.g., ICH-GCP, 21 CFR Part 11). Project, risk, and team management and an established track record leading teams to successful outcomes. Excellent planning and coordination of project delivery. Established track record collaborating with multi-functional teams in a matrix environment and partnering with/managing stakeholders, customers, and vendors.

PRA Health Sciences is looking for Contract Analyst I to join our dynamic team and embark on a rewarding career journey Review and analyze contracts, agreements, and legal documents to ensure compliance with company policies, standards, and applicable laws and regulations Identify and assess risks associated with contract terms, conditions, and obligations Collaborate with legal, procurement, and other relevant departments to ensure contract accuracy and completeness Negotiate contract terms and conditions, seeking favorable outcomes for the organization Assist in the development and maintenance of contract templates and standard operating procedures Conduct research on contract-related topics and provide guidance and recommendations based on industry best practices Maintain contract databases and repositories, ensuring accurate and up-to-date records Support contract administration activities, including contract amendments, renewals, and terminations Coordinate with internal stakeholders and external parties to facilitate contract execution and implementation Monitor contract compliance and performance, identifying and addressing any deviations or issues Provide contract-related training and guidance to internal teams as needed Stay informed about changes in relevant laws and regulations that may impact contract management practices Contribute to process improvement initiatives to streamline contract management workflows Assist in the resolution of contract disputes and conflicts

Hyderabad, India| Bengaluru, India| India| Remote Job Description Interpret clinical trial protocols to create and execute an effective clinical trial supply chain solution Create master English label text in accordance with relevant regulatory framework (e.g. Annex 13) Create and maintain demand forecasts and packaging plans so that packed clinical supplies are readily available in accordance with the project requirements Initiate packaging campaigns with the assigned vendor and provide oversight to ensure on-time delivery Setup, monitor, and where necessary, update study assigned Interactive Response Technology (IRT) systems to ensure study inventory is effectively managed Create an appropriate distribution plan and have oversight of the assigned vendor(s) executing it Ability to work independently and proactively to ensure that the supply of all trial materials is delivered to the right place at the right time Provide ongoing budget tracking activities so that projects are run efficiently and in accordance with client approved quotations Maintains 100% compliance on all assigned training and applies learnings to everyday practice Remain up to date in all GxP and regulatory requirements applicable to the role Leads client and vendor related meetings where necessary to discuss clinical supply chain topics or status updates Creates a Temperature Excursion management plan

Contract Analyst I - India, Bangalore - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development . What ICON can offer you: Our success depends on the quality of our people. That s why we ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here . Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there s every chance you re exactly what we re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply