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Tmf Specialist I – Trial Master File Operations & Clinical Documentation Management

Syneos Health
Syneos Health
1-3 years
preferred by company
Hyderabad
1 May 12, 2026
Job Description
Job Type: Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

TMF Specialist I – Trial Master File Operations & Clinical Documentation Management

Company: Syneos Health
Job Title: TMF Specialist I
Location: Hyderabad, India
Work Model: Hybrid
Job ID: 25107822
Department: Clinical Solutions / TMF Operations


About the Role

Syneos Health is hiring a TMF Specialist I for its Clinical Solutions team in Hyderabad. This hybrid opportunity is ideal for professionals experienced in Trial Master File (TMF) Operations, eTMF Management, Clinical Documentation, and Clinical Research Compliance.

The selected candidate will support the setup, maintenance, quality review, and close-out of Trial Master Files (TMF) while ensuring inspection-ready documentation in compliance with ICH-GCP guidelines, regulatory standards, and client requirements.

This opportunity is best suited for candidates with experience in eTMF operations, clinical documentation management, or clinical research coordination.


Key Responsibilities

TMF Operations & Clinical Documentation Management

  • Support:
    • Trial Master File (TMF) setup
    • TMF maintenance
    • TMF close-out activities
  • Ensure TMF documentation remains inspection-ready throughout the clinical trial lifecycle
  • Process study documentation according to:
    • SOPs
    • Work Instructions
    • ICH-GCP Guidelines
    • Regulatory requirements
    • Study-specific procedures

Document Processing & eTMF Management

  • Perform:
    • Document scanning
    • Indexing
    • Filing
    • Uploading into electronic TMF (eTMF) systems
  • Maintain secure and compliant document handling for:
    • Active studies
    • Archived studies
  • Ensure documentation accuracy, completeness, and security

Quality Review & Compliance Monitoring

  • Conduct Quality Reviews of TMF documents submitted by study teams
  • Perform Completeness Reviews against Expected Document Lists
  • Identify:
    • Missing TMF documentation
    • Incomplete records
    • Compliance gaps
  • Support remediation and documentation correction activities

Clinical Research Support

  • Collaborate with:
    • Clinical study teams
    • Documentation teams
    • Quality and compliance stakeholders
  • Support smooth documentation workflows across assigned studies
  • Maintain understanding of clinical trial documentation processes and regulatory expectations

Educational Qualification

Candidates should possess:

  • Bachelor’s or Master’s Degree in:
    • Life Sciences
    • Pharmacy
    • Dentistry
    • Related healthcare disciplines

Eligible qualifications include:

  • B.Sc / M.Sc
  • B.Pharm / M.Pharm
  • BDS

Required Experience

Mandatory Experience

Candidates should have either:

  • Minimum 1+ years of experience as an eTMF Specialist

OR

  • Minimum 2+ years of experience as a Clinical Research Coordinator (CRC)

OR

  • Relevant experience within a clinical research environment

Preferred Experience Areas

  • TMF Operations
  • Clinical Documentation Management
  • eTMF systems
  • Clinical trial coordination
  • Regulatory documentation handling