Novotech, a leading global Contract Research Organization (CRO), is hiring an experienced eTMF Specialist in Bangalore, India. This role is ideal for clinical research professionals with strong expertise in Trial Master File (TMF) management, GCP compliance, and eTMF systems, who want to work in a globally recognized CRO environment.
As an eTMF Specialist at Novotech, you will act as a subject matter expert responsible for ensuring TMFs remain inspection-ready and compliant with regulatory requirements throughout the clinical trial lifecycle.
Key Responsibilities – eTMF Specialist
- Lead and execute end-to-end TMF management across study start-up, maintenance, and close-out
- Act as TMF Subject Matter Expert (SME) and primary point of contact for TMF-related activities
- Develop, implement, and maintain TMF SOPs, TMF plans, and study-specific processes
- Ensure TMFs comply with ICH-GCP, regulatory requirements, DIA TMF Reference Model, and internal SOPs
- Perform TMF quality, completeness, and compliance reviews to ensure inspection readiness
- Collaborate with Clinical Operations, QA, and cross-functional teams on TMF filing and governance
- Manage eTMF systems, vendor coordination, system administration, and workflow optimization
- Generate and present TMF metrics, dashboards, and compliance reports
- Design and deliver TMF training programs for internal stakeholders
- Drive continuous improvement initiatives and automation of TMF processes
Qualifications & Experience Required
- Graduate degree in Clinical Research, Life Sciences, Pharmacy, or related discipline
- Minimum 3+ years of experience in TMF / eTMF management
- Strong knowledge of clinical trial documentation and TMF Reference Model (DIA)
- Hands-on experience with eTMF systems, workflows, and document management processes
- Experience coordinating TMF activities across internal teams and vendors
- Understanding of CRO operations and regulatory inspection expectations
- Strong communication, training, and stakeholder management skills
Why Join Novotech?
Novotech offers a collaborative, inclusive, and growth-oriented work environment with global exposure in clinical research and biotechnology.
Employee Benefits
- Flexible working options
- Paid parental leave for both parents
- Wellness and employee support programs
- Continuous learning and professional development
- Inclusive workplace supporting diversity and equal opportunity
- Strong leadership support and global career growth
Job Location
📍 Bangalore, Karnataka, India
Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore – 560103
Salary (Estimated)
💰 ₹10,00,000 – ₹16,00,000 per annum (CTC)
Salary may vary based on experience, skills, and interview performance.
How to Apply
