Executive – Trial Master File (eTMF)
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Job Location: Mumbai, India
Work Location: Sun House – Corporate Office
Job Type: Full-Time
Date Posted: January 6, 2026
About Sun Pharma
Sun Pharma is one of the world’s leading pharmaceutical companies, committed to delivering high-quality, affordable medicines globally. At Sun Pharma, we foster a culture of continuous growth, accountability, and collaboration—empowering professionals to build meaningful careers while contributing to impactful clinical research outcomes.
Job Summary
Sun Pharma Laboratories Ltd is seeking a detail-oriented Executive – Trial Master File (eTMF) to support clinical research documentation and ensure regulatory compliance across ongoing clinical trials. The role involves managing electronic Trial Master File systems, coordinating with cross-functional teams, and maintaining inspection-ready documentation in line with global regulatory standards.
Key Roles and Responsibilities
Trial Documentation & Administrative Support
Ensure all clinical trial-related documents are accurate, complete, and properly filed within the eTMF system.
Review, quality-check, and approve TMF documents to ensure compliance with internal SOPs and regulatory requirements.
Maintain strict version control and document lifecycle management.
eTMF System Management
Maintain and monitor the electronic Trial Master File (eTMF) system to ensure data integrity and system accuracy.
Establish and manage standardized TMF folder structures as per regulatory guidelines.
Regulatory Compliance & Inspection Readiness
Ensure the eTMF remains inspection-ready for health authorities and regulatory audits.
Act as the primary point of contact for TMF-related queries during internal and external audits or inspections.
Process Optimization
Continuously assess eTMF workflows and processes to improve operational efficiency and compliance standards.
Support implementation of best practices in TMF management.
Coordination & Communication
Coordinate with Clinical Research Associates (CRAs) for timely TMF updates and document reconciliation.
Conduct periodic TMF gap analyses and communicate deficiencies to relevant stakeholders for corrective action.
Educational Qualifications
Bachelor’s or Master’s degree in a health-related discipline such as Pharmacy, Life Sciences, Biology, Chemistry, Nursing, or Public Health,
OR
Postgraduate Diploma in Clinical Research.
Experience Requirements
0–2 years of relevant experience in clinical research, TMF management, or clinical documentation.
Exposure to eTMF systems and clinical trial processes will be an added advantage.
Why Join Sun Pharma?
At Sun Pharma, employee growth and well-being are central to our culture. We offer structured learning opportunities, professional development support, and a collaborative work environment that enables you to grow your career in global clinical research. Join us to contribute to high-impact research while advancing your professional journey.
Disclaimer
This job description outlines the general nature and level of work performed in this role. It is not intended to be an exhaustive list of responsibilities or qualifications. Sun Pharma reserves the right to modify duties or assign additional responsibilities based on business needs.
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