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.
