Executive – Trial Master File (eTMF)
Company: Sun Pharma Laboratories Ltd
Location: Sun House, Mumbai, India
Experience Required: 0–2 Years
Date Posted: 8th December 2025
Business Unit: Clinical Research
Job Type: Full-Time, Permanent
About Sun Pharma
At Sun Pharma, we empower professionals to “Create your own sunshine” by fostering an environment that encourages growth, ownership, and collaboration. Our culture promotes continuous learning, self-drive, and teamwork, helping you thrive while contributing to high-quality clinical research operations.
Key Responsibilities
Documentation & Administrative Support
Ensure all trial master file (TMF) documents are organized, accurate, and complete.
Review and approve documents for quality and compliance, maintaining version control.
Assist in preparation of inspection-ready TMF documentation.
System Oversight
Maintain and manage the electronic Trial Master File (eTMF) system, ensuring it is updated and functional.
Establish and maintain eTMF folder structures and document workflows.
Conduct periodic TMF gap analysis and coordinate with Clinical Research Associates (CRAs) to address deficiencies.
Regulatory Compliance Support
Ensure eTMF is inspection-ready in compliance with global regulatory requirements.
Serve as the point of contact for auditors regarding TMF-related queries during inspections.
Process Improvement
Continuously evaluate and enhance eTMF processes and workflows to improve efficiency, compliance, and data integrity.
Coordination & Communication
Coordinate and follow up with CRAs and study teams to update TMF documents promptly.
Communicate findings from TMF audits and gap analyses to relevant stakeholders.
Job Requirements
Educational Qualification
Bachelor’s or Master’s degree in Biology, Chemistry, Nursing, Pharmacy, Public Health, or related health sciences.
Post-graduate Diploma in Clinical Research is a plus.
Experience
0–2 years of relevant experience in clinical research administration, trial master file management, or eTMF oversight.
Skills & Competencies
Knowledge of GCP guidelines, ICH standards, and regulatory compliance.
Proficiency in electronic document management systems and MS Office tools.
Strong organizational, analytical, and communication skills.
Ability to coordinate with cross-functional teams and maintain audit-ready documentation.
Why Join Sun Pharma?
Gain exposure to end-to-end clinical trial operations and TMF management.
Develop regulatory compliance expertise and eTMF process skills.
Collaborate with multifunctional teams including Clinical Research, Regulatory Affairs, and Medical Affairs.
Opportunities for career development, professional growth, and skill enhancement.
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