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Tmf Specialist Ii

ICON PLC
3+ years
preferred by company
Chennai, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing

TMF Specialist II

Location: Chennai, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office With Flex (Hybrid)
Department: Clinical Operations / Trial Master File (TMF) / Clinical Document Management
Job Reference ID: JR142500
Industry: Clinical Research | CRO | Pharmaceutical | Biotechnology

Job Overview

ICON plc is hiring a TMF Specialist II for its clinical operations and document management team in Chennai. This opportunity is ideal for professionals with experience in Trial Master File (TMF) management, clinical document control, regulatory documentation, clinical trial compliance, eTMF systems, and clinical research operations.

As a TMF Specialist II, you will support the management, maintenance, and compliance of Trial Master File documentation for global clinical studies. You will ensure that essential clinical trial documents are accurate, complete, audit-ready, and maintained according to regulatory standards, client expectations, and internal procedures.

This role is ideal for professionals seeking career growth in clinical document management, TMF operations, eTMF administration, clinical trial compliance, and CRO clinical support functions.

Key Responsibilities

Trial Master File (TMF) Management

  • Support management and maintenance of Trial Master File documentation for clinical studies.
  • Ensure proper organization, completeness, and accessibility of essential study documents.
  • Maintain TMF documentation according to regulatory and operational standards.

Clinical Document Management

  • Handle document filing, indexing, tracking, review coordination, and archival support.
  • Ensure timely filing of essential clinical trial documents.
  • Maintain structured document workflows to support study operations.

eTMF Compliance & Documentation Quality

  • Ensure documentation meets:
    • Client requirements
    • Internal SOPs
    • Clinical research compliance standards
    • Regulatory expectations
    • Audit readiness requirements

Support inspection-ready documentation quality.

Cross-Functional Collaboration
Collaborate with:

  • Clinical Operations
  • Clinical Trial Management teams
  • Study start-up teams
  • Regulatory teams
  • Quality teams
  • Project stakeholders
  • Internal document management teams

Ensure timely and accurate document flow.

TMF Maintenance & Quality Oversight

  • Review TMF documentation for completeness and accuracy.
  • Identify missing, incomplete, or non-compliant documentation.
  • Support resolution of documentation gaps and quality issues.

Client & Internal Project Support

  • Contribute to TMF activities supporting:
    • Client service contracts
    • Internal ICON clinical operations
    • Study documentation workflows
    • Regulatory readiness initiatives

Document Filing & Tracking
Support:

  • Essential document tracking
  • Version control
  • Filing accuracy
  • Metadata consistency
  • Archival readiness

Required Educational Qualification
Candidates must have:

  • Bachelor’s Degree in:
    • Life Sciences
    • Pharmacy
    • Biotechnology
    • Healthcare
    • Clinical Research
    • Biomedical Sciences
    • Related discipline

Experience Required

  • Minimum 3+ years of relevant experience
  • Freshers are not eligible

Preferred experience:

  • Clinical research
  • Clinical document management
  • Trial Master File (TMF) operations
  • eTMF administration
  • Regulatory document handling