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Emmes Group, a globally recognized clinical research organization, is hiring a Senior TMF Specialist for its Bengaluru, Karnataka office. This is a full-time, on-site opportunity for experienced TMF professionals with strong expertise in eTMF operations, Veeva Vault, and ICH-GCP compliance.
With over 47 years of excellence in clinical research, Emmes is known for its work in cell and gene therapy, vaccines, infectious diseases, rare diseases, and neuroscience. This role offers an excellent opportunity to contribute to inspection-ready Trial Master Files (TMF) while collaborating with global stakeholders.
Key Responsibilities – Sr. TMF Specialist (Emmes)
- Act as functional TMF lead for assigned clinical studies
- Ensure the TMF remains inspection-ready by identifying and resolving completeness gaps
- Generate and present TMF quality metrics and reports to project teams
- Own and manage the TMF Plan / TMF Index and Expected Document List (EDL)
- Review Statements of Work (SoW) to align TMF scope and requirements
- Distinguish between in-scope and out-of-scope TMF activities
- Serve as SME for eTMF systems, particularly Veeva Vault eTMF
- Support and mentor TMF Specialists on best practices and compliance
- Represent TMF Operations during internal, external, and sponsor audits
- Manage audit findings and resolutions within Veeva Vault
- Contribute to SOPs, work instructions, templates, and quality frameworks
- Support process automation initiatives (VBA, RPA, AI/ML where applicable)
- Perform end-to-end TMF lifecycle activities including setup, maintenance, review, and close-out
Required Qualifications & Experience
- Bachelor’s degree (preferably in Life Sciences / Pharmacy / Scientific discipline)
- 3+ years of experience in TMF Operations or Clinical Operations
- Mandatory experience in eTMF systems and TMF filing procedures
- Proven expertise in TMF inspection readiness and gap analysis
- Strong working knowledge of ICH-GCP and TMF Reference Model
- Veeva Vault eTMF experience highly desirable
- Project management exposure preferred
- Experience with NIH-sponsored clinical trials is an added advantage
- Excellent communication skills with fluency in English
- Strong analytical, organizational, and stakeholder management skills
Why Join Emmes Group?
- Work with a globally respected CRO
- Exposure to complex and high-impact clinical research programs
- Strong focus on quality, compliance, and innovation
- Collaborative, people-driven work culture
- Opportunity to grow as a TMF subject matter expert
Job Location & Work Mode
- Location: Bengaluru, Karnataka, India
- Work Mode: On-site
- Employment Type: Full-time
Expected Salary (India)
- ₹8,00,000 – ₹14,00,000 per annum
(Salary may vary based on experience, TMF expertise, and Veeva proficiency)
How to Apply
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