Executive – Trial Master File (eTMF)
Company: Sun Pharmaceutical Laboratories Ltd
Business Unit: Clinical Research
Location: Mumbai – Sun House Corporate Office
Job Type: Full-Time
Experience Required: 0–2 Years
Posted Date: January 6, 2026
Job Overview
Sun Pharma is seeking a detail-oriented eTMF Executive to manage the Trial Master File (TMF) system and ensure all clinical trial documentation is accurate, complete, and inspection-ready. This role is ideal for early-career professionals in clinical research, offering exposure to regulatory compliance, eTMF systems, and clinical trial operations.
As part of our Clinical Research team, you will ensure the organization, quality, and accessibility of trial documents, maintain system integrity, and support audits and inspections for global clinical studies.
Key Responsibilities
Documentation Management
Organize, review, and maintain all trial-related documents for completeness and accuracy
Maintain version control and document approval workflows
Perform periodic TMF gap analysis and follow up with CRAs to ensure completeness
System Oversight
Maintain and manage the eTMF system, ensuring the folder structure is compliant and functional
Support system updates and continuous improvement initiatives
Regulatory Compliance
Ensure the eTMF is inspection-ready for regulatory authorities
Serve as the point of contact during audits and inspections for TMF-related queries
Ensure adherence to GCP, ICH guidelines, and internal SOPs
Process Improvement & Coordination
Identify areas for workflow enhancement and implement process improvements
Coordinate with CRAs and cross-functional teams to ensure timely document updates and compliance
Job Requirements
Educational Qualification
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, Biology, Chemistry, Public Health, or Postgraduate Diploma in Clinical Research
Experience
0–2 years of relevant experience in clinical research or trial documentation management
Exposure to eTMF systems, regulatory inspections, and clinical trial operations is preferred
Skills & Competencies
Strong attention to detail and organizational skills
Good written and verbal communication skills
Knowledge of GCP, ICH guidelines, and clinical trial documentation standards
Ability to work independently and collaborate in a team environment
Analytical mindset with a focus on compliance and quality assurance
Why Join Sun Pharma?
At Sun Pharma, your growth and success are a priority. You will have access to professional development opportunities, cross-functional collaboration, and exposure to global clinical trials. Join a company that fosters innovation, accountability, and a supportive environment to help you create your own sunshine every day.
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