Role & Responsibilities
• Maintain accurate, complete and inspection-ready Trial Master Files
• Review and approve TMF documents for regulatory compliance
• Manage version control and document consistency
• Maintain eTMF system structure, folders and system health
• Ensure continuous inspection readiness of TMF
• Act as TMF point of contact during audits and inspections
• Coordinate with CRAs for TMF updates
• Perform periodic TMF gap analysis and share findings
• Drive continuous improvement of eTMF workflows
Qualification
• Bachelor’s or Master’s degree in Life Sciences / Pharmacy / Nursing / Public Health / Related discipline
• PG Diploma in Clinical Research (preferred)
Experience
• 0–2 years in Clinical Research
• Freshers are eligible
Skills
• Knowledge of TMF/eTMF processes
• Understanding of ICH-GCP and regulatory documentation
• Strong attention to detail
• Good communication and coordination skills
• Proficiency in MS Office and document management systems
About the Company
Sun Pharma is India’s largest pharmaceutical company with a strong global presence, known for high-quality medicines and world-class clinical research standards.