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Tmf Specialist I – Trial Master File Operations & Clinical Documentation

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: ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

TMF Specialist I – Trial Master File Operations & Clinical Documentation

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 with experience 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), ensuring inspection-ready documentation throughout the clinical trial lifecycle in accordance with global regulatory standards and client requirements.

This opportunity is ideal for candidates with experience in eTMF operations, Clinical Research Coordination, or clinical documentation management.


Key Responsibilities

TMF Operations & 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 documentation standards

Electronic TMF (eTMF) Management

  • Perform:
    • Document scanning
    • Indexing
    • Filing
    • Uploading into eTMF systems
  • Maintain secure and compliant documentation for:
    • Active studies
    • Archived studies
  • Ensure document accuracy, completeness, and confidentiality

Quality Review & Compliance

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

Clinical Research Support

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

Educational Qualification

Candidates should possess a 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
  • eTMF systems
  • Clinical Documentation
  • Clinical Trial Coordination
  • Regulatory documentation handling