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Executive - Trial Master File

Sun Pharma
Sun Pharma
0-2 years
Not Disclosed
10 Jan. 9, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Executive – Trial Master File (eTMF)
Company: Sun Pharma Laboratories Ltd
Business Unit: Clinical Research
Location: Sun House, Mumbai, India
Posted Date: January 6, 2026

Company Overview:
Sun Pharma empowers employees to “Create Your Own Sunshine” by fostering a collaborative and growth-oriented work environment. With a global presence in pharmaceuticals, Sun Pharma encourages professionals to take charge of their careers, continuously improve, and contribute meaningfully to clinical research and healthcare initiatives.

Position Overview:
Sun Pharma is seeking a motivated eTMF Executive with 0–2 years of experience in clinical research. The candidate will be responsible for managing Trial Master File (TMF) processes, maintaining electronic TMF systems, ensuring compliance with regulatory standards, and supporting site and CRA coordination. The ideal candidate will be detail-oriented, organized, and familiar with Good Clinical Practice (GCP) and TMF management principles.

Key Responsibilities:

Documentation and Administrative Support:

  • Organize and maintain all trial-related documents accurately and completely.

  • Review and approve documents to ensure quality and compliance.

  • Maintain version control for all trial documents.

System Oversight:

  • Maintain and monitor the eTMF system to ensure functionality and compliance.

  • Establish and maintain eTMF structure, folder systems, and document indexing.

Regulatory Compliance Support:

  • Ensure the eTMF system is inspection-ready for health authorities.

  • Serve as the point of contact during inspections for TMF-related queries.

Process Improvement:

  • Continuously evaluate and improve eTMF workflows and processes to enhance efficiency and compliance.

Coordination & Communication:

  • Coordinate with Clinical Research Associates (CRAs) to ensure timely TMF updates.

  • Perform periodic TMF gap analyses and communicate deficiencies to CRAs for resolution.

Educational Requirements:

  • Bachelor’s or Master’s degree in a health-related field (Biology, Chemistry, Nursing, Pharmacy, Public Health) or Postgraduate Diploma in Clinical Research.

Experience Requirements:

  • 0–2 years of relevant experience in clinical research or TMF management.

Why Join Sun Pharma:
Sun Pharma prioritizes your growth, well-being, and career development. Employees benefit from professional development opportunities, a collaborative work culture, and robust support for achieving career milestones. Join Sun Pharma to contribute to impactful clinical research and be part of a team shaping the future of healthcare.

Apply Today:
If you are detail-oriented, organized, and eager to advance your career in clinical research, apply now to join Sun Pharma as an eTMF Executive in Mumbai.