Senior TMF Specialist Job at Emmes in Bengaluru. Full-time on-site CRO job with Veeva eTMF, GCP, and TMF expertise required.
Company: Emmes
Job Title: Senior TMF Specialist
Location: Bengaluru, Karnataka, India
Job Type: Full-Time
Work Mode: On-site
Industry: Clinical Research / CRO
Experience Required: 3+ Years
About Emmes Group
Emmes Group is a global clinical research organization with over 47 years of experience, partnering with government agencies, biopharma companies, and public–private research programs. Emmes specializes in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience, with a strong commitment to improving patient outcomes through innovative clinical research. Senior TMF Specialist Job at Emmes
Job Summary
The Senior TMF Specialist will act as a functional lead for Trial Master File (TMF) operations and ensure TMFs are inspection-ready at all times. This role involves oversight of TMF completeness, quality metrics, eTMF systems, and close collaboration with project teams, sponsors, and internal stakeholders, while ensuring compliance with ICH-GCP and TMF Reference Model requirements. Senior TMF Specialist Job at Emmes
Key Responsibilities
- Lead and manage study TMFs to maintain inspection readiness
- Identify TMF completeness gaps and drive timely resolution
- Generate TMF metrics and reports to support project teams
- Act as Subject Matter Expert (SME) for eTMF systems and TMF processes
- Own and manage TMF Plan, TMF Index, and Expected Document Lists (EDL)
- Review Statements of Work (SoW) to align TMF scope and responsibilities
- Support sponsor and internal audits; manage TMF audit findings in Veeva Vault
- Ensure TMF structure complies with GCP, GDP, and TMF Reference Model
- Mentor and guide TMF Specialists on best practices
- Support SOPs, work instructions, templates, and TMF quality frameworks
- Contribute to system enhancements, automation, RPA, AI/ML initiatives
- Perform TMF lifecycle activities including set-up, maintenance, review, and close-out
Required Qualifications & Skills
- Bachelor’s degree (preferably in a scientific discipline)
- Minimum 3+ years experience in TMF Operations or Clinical Operations
- Strong knowledge of TMF filing procedures and eTMF systems
- Proven experience maintaining inspection-ready TMFs
- Hands-on experience with Veeva Vault eTMF highly preferred
- Sound understanding of ICH-GCP, TMF Reference Model, and regulatory guidelines
- Ability to manage multiple priorities in a fast-paced environment
- Excellent communication, documentation, and stakeholder management skills
- Experience with NIH-sponsored clinical trials is an advantage
- Strong attention to detail, analytical thinking, and problem-solving skills
Why Join Emmes?
- Work with a globally recognized CRO on impactful clinical research
- Exposure to complex, high-profile clinical programs
- Collaborative, performance-driven, and people-focused culture
- Opportunities for career growth in TMF Operations and Clinical Systems
How to Apply
Interested candidates can apply online through the official Emmes careers page or LinkedIn job listing. Shortlisted applicants will be contacted directly by the hiring team for further steps. Senior TMF Specialist Job at Emmes
For verified pharma job updates, visit PharmaJobHub.in – India’s trusted pharma career portal.
Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
