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Tmf Specialist Ii

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ICON
3+ years
Not Disclosed
Chennai, India
2 May 7, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

TMF Specialist II

Location: Chennai, India
Work Mode: Office With Flex
Job Type: Full-Time
Experience Required: Minimum 3+ Years in Clinical Research, TMF Management, or Document Management
Industry: Clinical Research / Pharmaceutical / CRO


Job Overview

We are seeking a detail-oriented and organized TMF Specialist II to support Trial Master File (TMF) operations and clinical document management activities for global clinical research projects. The selected candidate will play a key role in maintaining accurate, compliant, and audit-ready clinical trial documentation while supporting both client projects and internal operational requirements.

This role is ideal for professionals with expertise in TMF documentation, clinical trial records management, regulatory compliance, and document control within pharmaceutical, biotechnology, or CRO environments.


Key Responsibilities

TMF Documentation & Management

  • Support Trial Master File (TMF) documentation and document management activities across clinical studies.
  • Maintain and organize:
    • Clinical trial documents
    • Regulatory documentation
    • Essential study records
    • Electronic TMF files
  • Ensure documentation is:
    • Accurate
    • Complete
    • Timely
    • Audit-ready

Clinical Document Control

  • Assist in:
    • Filing
    • Reviewing
    • Tracking
    • Managing TMF documentation
      throughout the clinical trial lifecycle.
  • Ensure compliance with:
    • Client requirements
    • Internal procedures
    • Regulatory standards
    • TMF guidelines
  • Support document reconciliation and quality review activities.

Cross-Functional Collaboration

  • Collaborate with:
    • Clinical Operations teams
    • Regulatory Affairs teams
    • Quality Assurance
    • Study teams
    • Project stakeholders
  • Ensure timely submission and filing of essential clinical trial documentation.
  • Support smooth communication between operational teams and TMF management functions.

Regulatory Compliance & Quality Standards

  • Follow and support compliance with:
    • ICH-GCP guidelines
    • TMF reference models
    • Clinical research regulations
    • Sponsor SOPs
  • Maintain high standards of:
    • Documentation quality
    • Data integrity
    • Inspection readiness
    • Regulatory compliance

Operational Support & Process Improvement

  • Contribute to:
    • Client service contracts
    • Internal business operations
    • TMF workflow improvements
    • Documentation process optimization
  • Support continuous improvement initiatives to enhance operational efficiency and compliance standards.

Required Qualifications

Educational Qualifications

Required Qualification:

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

Preferred Qualification

  • Certifications in:
    • Clinical Research
    • TMF Management
    • Regulatory Documentation
    • Clinical Operations

Experience Requirements

Required Experience

  • Minimum 3+ years of experience in:
    • Clinical Research
    • TMF Management
    • Clinical Documentation
    • Document Management
    • Pharmaceutical or CRO environments
  • Strong understanding of:
    • Clinical trial documentation
    • TMF processes
    • Regulatory compliance
    • Inspection readiness

Preferred Experience

  • Experience working with:
    • Electronic TMF (eTMF) systems
    • Document management tools
    • Clinical operations teams
    • Regulatory workflows

Freshers are not eligible for this specialist-level role.