Tata Consultancy Services (TCS), one of India’s leading global IT and life sciences service providers, is hiring eTMF Specialists for its clinical operations team. This opportunity is ideal for professionals with 1–3 years of experience in eTMF, TMF documentation, and ICH-GCP–compliant clinical trial processes who are looking to grow their careers in regulatory-focused clinical research roles.

The eTMF Specialist role at TCS involves end-to-end Trial Master File management, quality control, inspection readiness, and collaboration with cross-functional clinical teams. Positions are open across Mumbai and Pune locations.

Key Responsibilities – eTMF Specialist (TCS)

• Collaborate with the eTMF Team Lead to ensure Trial Master File (TMF) business requirements are met proactively
• Act as document creator, QC reviewer, and primary TMF contact for assigned studies
• Manage TMF processing, indexing, filing, and reconciliation activities
• Ensure inspection readiness and ongoing TMF completeness and accuracy
• Perform discrepancy management as per SOPs, timelines, and regulatory expectations
• Support internal and external regulatory inspections and audits
• Provide inputs to TMF-related SOPs, guidelines, and system user guides
• Communicate TMF issues and risks to senior eTMF stakeholders in a timely manner

Eligibility & Qualifications

• Experience: 1 to 3 years in eTMF, TMF operations, or clinical documentation
• Education: Degree in Life Sciences, Pharmacy, Clinical Research, or related discipline
• Core Knowledge:
  • ICH-GCP guidelines
  • Clinical trial documentation and TMF lifecycle
  • Regulatory inspection preparedness
• Skills:
  • Strong attention to detail
  • Quality control and compliance mindset
  • Effective communication and cross-functional collaboration

Why Join TCS?

• Opportunity to work with a global life sciences and clinical research team
• Exposure to regulatory inspections and global clinical trials
• Structured career growth in eTMF, Clinical Operations, and Regulatory Compliance
• Hybrid work model with locations in Mumbai and Pune
• Competitive compensation aligned with industry standards

Salary (Estimated)

• ₹4,50,000 – ₹7,50,000 per annum (INR)
  (Salary may vary based on experience, location, and interview performance)

Job Location

• Mumbai (All Areas), Maharashtra
• Pune, Maharashtra

How to Apply

Application Link