TMF Specialist I

CHENNAI (IN)HYBRIDPOSTED: 8/15/2026
PHARMAFull-time
HIRING ORGANIZATIONICON PLCTechnology
ICON plc

ROLE DEFINITION & RESPONSIBILITIES

Core Responsibilities

TMF Document Management: Gain operational familiarity with Trial Master File (TMF) structure and execute document management activities across clinical trial programs.
Filing & Organization: Assist in the systematic indexing, filing, maintenance, and quality checking of essential clinical study documentation to support Trial Master Files.
Compliance & Procedural Adherence: Ensure all documentation practices strictly comply with client contract specifications, ICON Standard Operating Procedures (SOPs), and ICH-GCP regulatory requirements.
Cross-Functional Collaboration: Coordinate with clinical trial project teams, study managers, and client services stakeholders to ensure timely and complete collection of regulatory and operational artifacts.

Technical & Domain Standards

Understanding of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and standard TMF reference models (such as DIA TMF Reference Model).
Strong adherence to clinical trial documentation quality and audit-readiness standards.

Benefits & Total Rewards

Comprehensive health and wellbeing coverage including medical, dental, and vision insurance.
Retirement savings plans, life assurance, disability coverage, and structured professional development pathways.

REQUIRED VERIFIED SKILLS

Trial Master File (TMF)
eTMF
Clinical Document Management
ICH-GCP
Good Documentation Practices (GDP)
Clinical Research
Quality Control
Regulatory Documentation

COMPENSATION & REWARDS

3.5L - 6.0L per annum

ORGANIZATION CONTEXT & CULTURE

ICON plc is actively hiring for this position.

INDUSTRY: Technology

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