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Manager, Tmf Operations

Icon Plc
ICON PLC
2+ years
preferred by company
Chennai, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill

Manager, TMF Operations

Location: Chennai, India
Company: ICON plc
Job Type: Full-Time
Work Mode: Office With Flex (Hybrid)
Department: Clinical Research / TMF Operations
Job Reference ID: JR143093
Application Deadline: 30 May 2026

Job Overview

ICON plc is hiring a Manager, TMF Operations for its Chennai office. This leadership role is ideal for experienced clinical research professionals with strong expertise in Trial Master File (TMF) management, clinical documentation compliance, audit readiness, GCP, and team leadership.

As a TMF Operations Manager, you will lead the team responsible for maintaining accurate, complete, and inspection-ready Trial Master Files across multiple clinical studies. This role plays a critical part in ensuring regulatory compliance and successful clinical trial execution.

This opportunity is highly suitable for professionals aiming to grow in clinical operations leadership, TMF governance, regulatory documentation management, and global clinical trial compliance.

Key Responsibilities

TMF Management & Oversight

  • Lead TMF Operations team across multiple clinical studies
  • Oversee Trial Master File maintenance throughout the study lifecycle
  • Ensure essential clinical trial documentation is accurate, complete, and audit-ready
  • Maintain compliance with TMF standards and regulatory expectations

Document Collection & Filing

  • Supervise collection, review, QC, and filing of essential study documents
  • Ensure timely document updates in electronic TMF systems
  • Monitor completeness and quality of documentation

Regulatory Compliance

Ensure TMF processes comply with:

  • ICH-GCP guidelines
  • Global clinical trial regulations
  • Sponsor requirements
  • Internal SOPs
  • Inspection readiness standards

Cross-Functional Collaboration

Work closely with:

  • Clinical Operations
  • Regulatory Affairs
  • Quality Assurance
  • Study Management teams
  • Sponsors / clients
  • External stakeholders

Drive alignment to maintain high documentation quality.

Audit & Inspection Readiness

  • Ensure TMF is inspection-ready at all times
  • Support regulatory audits and client inspections
  • Identify documentation gaps and drive remediation
  • Manage audit findings and corrective actions

Process Improvement

  • Develop TMF governance strategies
  • Improve document management workflows
  • Create/update SOPs, processes, and compliance frameworks
  • Drive continuous operational efficiency improvements

Quality Metrics Monitoring

  • Track TMF health and compliance metrics
  • Identify risk areas
  • Implement CAPA and quality improvement initiatives

Team Leadership

  • Manage, mentor, and develop TMF team members
  • Provide training and performance guidance
  • Build a strong compliance-focused team culture

Required Qualifications

Bachelor’s degree in:

  • Life Sciences
  • Clinical Research
  • Pharmacy
  • Biotechnology
  • Healthcare
  • Related scientific discipline

Preferred:

  • Advanced degree
  • Clinical operations certification
  • Document management certification

Required Experience

Strong experience in:

  • TMF management
  • Clinical operations
  • Clinical documentation management
  • Pharmaceutical / CRO environment

Leadership experience required:

  • Team management
  • Process ownership
  • Cross-functional stakeholder handling

Required Skills

Mandatory Skills

  • Trial Master File (TMF)
  • eTMF Systems
  • Clinical Documentation Management
  • ICH-GCP
  • Regulatory Compliance
  • Audit Readiness
  • Inspection Support
  • Clinical Operations
  • Quality Management
  • SOP Development
  • Team Leadership
  • Risk Management
  • Process Improvement
  • Document Review & QC

Preferred Skills

  • CAPA Management
  • Vendor Coordination
  • Global Clinical Trial Documentation
  • Metrics Reporting
  • Client Management