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Senior Tmf Specialist

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ICON
5+ years
Not Disclosed
Chennai, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills:

Senior TMF Specialist

Location: Chennai, India
Work Mode: Office Based / Office With Flex
Job Type: Full-Time
Experience Required: Minimum 5+ Years in TMF Management with 2–3 Years in Periodic File Review, Cross Checks & Co-Dependency Checks
Industry: Clinical Research / Pharmaceutical / CRO


Job Overview

We are seeking an experienced and detail-oriented Senior TMF Specialist to manage Trial Master File (TMF) operations and ensure clinical trial documentation remains inspection-ready and compliant with global regulatory standards. The selected candidate will play a critical role in conducting periodic TMF reviews, identifying missing documentation, performing co-dependency and cross checks, and supporting high-quality eTMF management activities.

This role is ideal for professionals with expertise in TMF operations, Veeva Vault, clinical trial documentation, periodic file review, and regulatory compliance within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

TMF Review & Inspection Readiness

  • Perform comprehensive:
    • eTMF completeness reviews
    • Periodic file reviews
    • Milestone-based TMF checks
  • Ensure Trial Master Files are:
    • Accurate
    • Complete
    • Audit-ready
    • Inspection-ready
  • Identify and resolve missing or incomplete documentation within assigned studies.

Cross Checks & Co-Dependency Reviews

  • Conduct:
    • Co-dependency checks
    • Cross-document verification
    • Metadata validation
    • Document relationship analysis
  • Ensure document consistency and compliance across clinical study files.
  • Review Expected Document Lists (EDL) and update them as required.

Veeva Vault & eTMF Management

  • Utilize Veeva Vault and other electronic TMF systems to:
    • Review documents
    • Track missing files
    • Maintain TMF quality
    • Monitor filing compliance
  • Ensure proper metadata assignment and document indexing.
  • Maintain accurate electronic document records throughout the study lifecycle.

ALCOEA & Quality Compliance

  • Perform ALCOEA checks to ensure:
    • Data integrity
    • Accuracy
    • Legibility
    • Consistency
    • Regulatory compliance
  • Support adherence to:
    • ICH-GCP guidelines
    • TMF reference models
    • Sponsor SOPs
    • Regulatory standards

Cross-Functional Collaboration

  • Collaborate with:
    • TMF Leads
    • Clinical Operations teams
    • Study teams
    • Regulatory stakeholders
  • Follow up on action items and ensure timely closure of documentation gaps.
  • Support smooth communication and workflow coordination across project teams.

Training & Operational Support

  • Conduct training sessions for internal teams on:
    • TMF processes
    • Documentation quality
    • Compliance standards
    • Review procedures
  • Address team queries and support operational best practices.
  • Ensure SLA timelines and stakeholder deliverables are consistently met.

Required Qualifications

Educational Qualifications

Required Qualification:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Clinical Research
    • Biotechnology
    • Healthcare
    • Or related scientific disciplines

Preferred Qualification

  • Advanced Degree or certifications in:
    • Clinical Research
    • TMF Management
    • Regulatory Documentation
    • Clinical Operations