Are you a clinical research professional ready to take the next step with one of India’s most trusted organizations? 🌍 Tata Consultancy Services (TCS) is hiring eTMF Specialists for its Mumbai and Pune locations. This opportunity is ideal for candidates with 1–3 years of experience in eTMF, TMF management, or clinical documentation who want to work in a structured, compliance-driven environment.
If you have hands-on exposure to ICH-GCP guidelines, clinical trial documentation, and inspection readiness, this role could be a strong next step in your professional journey. Let’s break it down 👇
🏢 About Tata Consultancy Services (TCS)
TCS is a global leader in IT services, consulting, and business solutions, with a strong footprint in life sciences and clinical research operations. The organization partners with pharmaceutical, biotechnology, and healthcare companies worldwide. Working at TCS means being part of a process-driven culture that emphasizes quality, compliance, and continuous learning 📈.
📌 Job Overview: eTMF Specialist
- Role: eTMF Specialist
- Experience Required: 1–3 years
- Job Locations: Mumbai & Pune
- Openings: 8
- Salary: Not Disclosed
- Employment Type: Full-time
This role focuses on managing electronic Trial Master Files (eTMF) and ensuring regulatory compliance throughout the clinical trial lifecycle.
🧠 Key Skills Required
✅ Must-Have Skills
- eTMF (Electronic Trial Master File)
- TMF documentation & quality control
- Understanding of clinical trial processes
➕ Good-to-Have Skills
- ICH-GCP guidelines
- Clinical Research Operations
- CTMS (Clinical Trial Management System)
- Regulatory inspection support
- TMF reconciliation & discrepancy management
📝 Roles & Responsibilities
As an eTMF Specialist at TCS, you’ll play a critical role in maintaining inspection-ready TMFs.
📂 TMF Management & Documentation
- Act as a document creator and quality checker for TMF artifacts
- Ensure completeness, accuracy, and timely filing
🤝 Cross-Functional Collaboration
- Work closely with the eTMF Team Lead
- Coordinate with internal stakeholders to close documentation gaps
🔍 Quality Control & Compliance
- Perform routine QC checks aligned with ICH-GCP and internal SOPs
- Identify and escalate TMF-related risks or issues
📊 Discrepancy & Issue Management
- Manage TMF discrepancies within defined timelines
- Maintain clear documentation of corrective actions
📘 SOPs & Process Improvement
- Contribute to SOPs, work instructions, and user guides
- Support continuous improvement initiatives
🛡️ Inspection Readiness
- Support internal audits and external regulatory inspections
- Keep TMFs inspection-ready at all trial stages
🎯 Who Should Apply?
This role is best suited for:
- ✔ Professionals with 1–3 years of eTMF/TMF experience
- ✔ Candidates familiar with clinical trial documentation and regulatory standards
- ✔ Individuals seeking long-term growth in clinical operations and compliance
- ✔ Those who enjoy process-driven, quality-focused environments
🌟 Why Consider This Opportunity?
✨ Work with a globally recognized organization
✨ Exposure to international clinical trial standards
✨ Strengthen expertise in eTMF & inspection readiness
✨ Clear growth pathways in life sciences and regulatory domains
✨ Work in major pharma hubs: Mumbai & Pune
📍 Location Advantage: Mumbai & Pune
Both cities are major hubs for clinical research, CROs, and pharma companies, offering excellent exposure, networking, and long-term growth opportunities 🏙️.
📢 Final Thoughts
The eTMF Specialist role at TCS is a strong opportunity for professionals looking to deepen their expertise in Trial Master File management within a reputed global organization. If you’re passionate about compliance, documentation quality, and clinical research excellence, this role can significantly accelerate your career 🚀.
Tip: Keep your resume crisp—highlight eTMF systems used, QC activities, reconciliation experience, and inspection readiness examples.
Best of luck with your application! 🍀
