Senior TMF Specialist – Trial Master File (eTMF)
Location: Chennai, Tamil Nadu, India
Job ID: JR142071
Department: Regulatory Document Management
Employment Type: Full-Time | Office-Based
Industry: Clinical Research | Regulatory Affairs | Trial Master File Management | CRO
Senior TMF Specialist Job in Chennai – Clinical Research & Regulatory Documentation
A leading global clinical research organization is hiring a Senior TMF Specialist in Chennai to manage and oversee Trial Master File (TMF) activities across global clinical trials.
This role is critical in ensuring inspection readiness, regulatory compliance, and document integrity within electronic Trial Master File (eTMF) systems. The ideal candidate will have strong expertise in TMF periodic reviews, document completeness checks, regulatory compliance standards, and Veeva Vault systems.
Role Overview
The Senior TMF Specialist will be responsible for managing and reviewing Trial Master File documentation to ensure alignment with global regulatory requirements including ICH-GCP and health authority expectations.
This position plays a key role in maintaining inspection readiness, identifying missing documents, conducting metadata and ALCOEA checks, and supporting study teams to close compliance gaps efficiently.
Key Responsibilities
Trial Master File Oversight & Review
Perform comprehensive eTMF completeness checks, including milestone and periodic reviews.
Conduct cross-checks and co-dependency checks to identify missing or misfiled documents within Veeva Vault eTMF.
Ensure TMF is inspection-ready at all times for allocated studies.
Maintain and update the Expected Document List (EDL) as required.
Compliance & Quality Assurance
Perform ALCOEA (Attributable, Legible, Contemporaneous, Original, Accurate, Enduring, Available) checks and metadata validation.
Ensure documents meet global regulatory standards and internal SOP requirements.
Identify gaps and proactively follow up with study teams to resolve outstanding TMF action items.
Maintain adherence to agreed SLAs and stakeholder deliverables.
Collaboration & Training
Collaborate with TMF Leads and study teams to gather review requirements.
Conduct internal training sessions and address team queries related to TMF best practices.
Support continuous process improvements in regulatory document management workflows.
Required Experience
Minimum 7+ years of experience in Trial Master File (TMF) management and periodic review within a CRO, pharmaceutical, or biotech organization.
At least 2–3 years of hands-on experience in missing document identification and TMF reconciliation activities.
Proven experience ensuring inspection readiness and regulatory compliance.
Strong working knowledge of eTMF systems, preferably Veeva Vault.
Educational Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline.
Advanced degree preferred.
Technical Skills & Competencies
Strong understanding of:
ICH-GCP guidelines
Global TMF regulations and best practices
Regulatory inspection readiness standards
Hands-on experience with:
Veeva Vault eTMF
Electronic Document Management Systems (EDMS)
Proficiency in Microsoft Excel and document tracking tools.
Excellent organizational and analytical skills.
High attention to detail with strong document compliance awareness.
Strong communication skills and ability to collaborate with cross-functional global teams.
Why Apply for This Senior TMF Specialist Role?
Opportunity to work with a globally recognized clinical research organization.
Exposure to global regulatory audits and inspection readiness programs.
Competitive compensation and comprehensive employee benefits.
Health insurance and retirement planning support.
Employee Assistance Program and wellness initiatives.
Inclusive and performance-driven work culture.
Equal Opportunity Statement
The organization is committed to maintaining a diverse, inclusive, and accessible workplace. All qualified applicants will receive equal consideration for employment without discrimination based on race, religion, gender, disability, sexual orientation, or protected veteran status.
Reasonable accommodations are available for candidates requiring assistance during the recruitment process.
Keywords for Search Optimization
Senior TMF Specialist Jobs Chennai, eTMF Jobs India, Trial Master File Careers, Veeva Vault TMF Jobs, Regulatory Document Management Jobs, Clinical Research Compliance Roles, CRO Jobs Chennai, ICH-GCP TMF Specialist Careers
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