Clinical Research Job at Sun Pharma, Mumbai
Want to lead Real-World Evidence (RWE) studies and clinical research programs at one of India’s largest pharmaceutical companies? Sun Pharma is recruiting for the position of Lead – Clinical Research (RWE), Medical Affairs at its Corporate Office in Mumbai. This leadership role offers an opportunity to drive non-regulatory clinical studies, observational research, investigator-initiated studies, and real-world evidence programs. The selected candidate for the Clinical Research Job at Sun Pharma Careers will collaborate with cross-functional teams, CROs, investigators, and key stakeholders to ensure the successful execution of clinical research projects. If you have a strong background in Medical Affairs, clinical research operations, and people management, this Job in Mumbai could be an excellent career opportunity.
About the Company:
Sun Pharmaceutical Industries Ltd. is one of the world’s leading specialty generic pharmaceutical companies and India’s largest pharmaceutical organization. The company is committed to improving patient outcomes through innovation, research, and high-quality medicines. With a strong global presence across multiple therapeutic areas, Sun Pharma continues to invest in scientific excellence, clinical research, and healthcare advancements. The company promotes a culture of growth, ownership, collaboration, and continuous learning.
Job Details:
- Job Title: Lead – Clinical Research (RWE), Medical Affairs
- Department: Medical Affairs
- Reporting To: General Manager – Medical Affairs, India
- Location: Mumbai (Sun House – Corporate Office)
- Qualification Required: MD Pharmacology
- Experience Required: More than 7 Years
- Employment Type: Full-Time
- Team Management: 4 Direct Reports
- Work Mode: Primarily Office-Based
- Travel Requirement: Average 4–5 Days of Travel Outside Mumbai
- Functional Area: Clinical Research, Real-World Evidence (RWE), Medical Affairs
Key Responsibilities:
Clinical Research & Study Management
- Create, adapt, and update SOPs and work instructions for non-regulatory clinical studies.
- Ensure compliance with ICH-GCP guidelines, study protocols, and applicable regulations.
- Develop monitoring systems and trackers to oversee study execution.
- Manage observational studies, registries, EMR studies, PRO studies, and investigator-initiated studies in this Clinical Research Job.
- Maintain Trial Master Files in compliance with applicable guidelines.
- Conduct risk assessments and implement mitigation strategies for ongoing studies.
- Manage audits, inspections, and CAPA implementation.
- Develop monthly dashboards and performance updates for Medical Affairs studies.
CRO & Vendor Management
- Identify and manage CROs for effective study execution.
- Evaluate CRO performance through periodic assessments.
- Coordinate regulatory submissions with internal stakeholders.
- Ensure vendor compliance with organizational policies and procedures in this Job in Mumbai.
- Oversee study agreements and financial contracts with investigators and sites.
In-House Clinical Study Management
- Conduct site feasibility assessments and investigator selection.
- Manage ethics committee submissions and approvals.
- Oversee site initiation, monitoring, and close-out activities.
- Ensure participant recruitment and study data quality.
- Monitor adverse event reporting and pharmacovigilance compliance.
- Coordinate statistical analysis, data management, and query resolution.
- Manage clinical trial budgets and financial accountability.
Leadership & Team Management
- Recruit, develop, and mentor clinical research professionals.
- Drive team performance metrics and operational excellence.
- Strengthen collaboration across Medical Affairs and cross-functional teams.
- Support stakeholder engagement with internal and external partners at Sun Pharma Careers.
- Lead talent development initiatives and individual development plans.
Educational Requirements for this Clinical Research Job:
- MD Pharmacology from a recognized institution.
- Formal training in clinical trial methodologies and research design.
- Training in ICH-GCP principles and clinical research practices.
- Strong academic background with research experience.
Skills Required:
- Strong expertise in clinical research operations.
- Experience in Real-World Evidence (RWE) studies.
- Thorough understanding of ICH-GCP guidelines.
- Knowledge of ICMR Guidelines 2017 and Drugs & Cosmetics Act regulations.
- Clinical study planning and execution expertise.
- CRO and vendor management skills.
- Budget planning and financial management capabilities.
- Risk assessment and CAPA management expertise.
- Strong analytical and strategic thinking abilities.
- Excellent stakeholder management and collaboration skills.
- Leadership and people management capabilities.
- Effective communication and presentation skills.
- Ability to work successfully in a matrix organization.
- Strong problem-solving and decision-making skills.
Benefits of the Clinical Research Job:
- Opportunity to lead high-impact clinical research and RWE initiatives.
- Work with India’s leading pharmaceutical company.
- Exposure to large-scale observational and non-regulatory studies.
- Leadership role with direct people management responsibilities.
- Opportunity to collaborate with investigators, CROs, and healthcare experts.
- Involvement in innovative research and evidence-generation programs.
- Career growth within a globally recognized pharmaceutical organization.
- Exposure to cross-functional strategic decision-making.
- Opportunity to contribute to healthcare advancements and patient outcomes.
- A Dynamic work environment focused on continuous learning and professional development.
