Manager, TMF Operations
Job Title: Manager, TMF Operations
Location: Chennai, India
Work Model: Office With Flex (Office-Based)
Employment Type: Full-Time
Job Requisition ID: JR143093
Application Deadline: June 30, 2026
Company: ICON plc
About ICON
ICON is a global healthcare intelligence and clinical research organization committed to accelerating the development of innovative medicines and therapies that improve patient lives worldwide.
Built on the values of Integrity, Collaboration, Agility, and Inclusion, ICON partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality clinical research solutions while maintaining the highest standards of compliance and operational excellence.
Position Overview
ICON is seeking an experienced Manager, TMF Operations to lead Trial Master File (TMF) management activities across multiple clinical research programs.
This leadership role is responsible for overseeing TMF operations, ensuring document quality, regulatory compliance, inspection readiness, and operational excellence throughout the clinical trial lifecycle. The Manager will lead a team of TMF professionals, collaborate with cross-functional stakeholders, and drive continuous process improvements to support successful clinical trial execution.
The position requires strong expertise in TMF management, leadership, regulatory compliance, inspection readiness, and team development.
Key Responsibilities
TMF Operations Leadership
Lead and manage the TMF Operations team responsible for Trial Master File maintenance across multiple clinical studies.
Establish operational priorities and ensure timely delivery of TMF-related activities.
Monitor team performance and workload allocation.
Foster a culture of quality, accountability, and continuous improvement.
Trial Master File Management
Oversee the management and maintenance of electronic and/or paper Trial Master Files.
Ensure TMF documentation remains:
Accurate
Complete
Current
Inspection Ready
Support TMF activities throughout the entire clinical trial lifecycle.
Ensure compliance with TMF Reference Model standards and organizational requirements.
Document Collection & Quality Oversight
Oversee the collection, review, reconciliation, and filing of essential clinical trial documents.
Ensure timely processing and filing of study documentation.
Review document quality and completeness.
Ensure proper version control and document traceability.
Regulatory Compliance
Ensure TMF operations comply with:
ICH-GCP Guidelines
Global Regulatory Requirements
Sponsor Requirements
Internal SOPs
TMF Industry Best Practices
Maintain inspection and audit readiness across all assigned studies.
Identify and mitigate compliance risks proactively.
Audit & Inspection Readiness
Ensure Trial Master Files are prepared for:
Regulatory Inspections
Sponsor Audits
Client Reviews
Internal Quality Audits
Lead remediation activities when gaps or findings are identified.
Coordinate responses to inspection and audit observations.
Cross-Functional Collaboration
Partner with:
Clinical Operations
Regulatory Affairs
Quality Assurance
Study Management Teams
Sponsors and Clients
Ensure alignment on documentation requirements and TMF expectations.
Support study teams in resolving TMF-related issues.
Process Improvement & Strategy
Develop and implement TMF management strategies, policies, and procedures.
Evaluate existing workflows and identify opportunities for optimization.
Drive operational excellence initiatives to improve efficiency and compliance.
Promote standardization and best practices across TMF operations.
Quality Metrics & Performance Monitoring
Monitor and analyze TMF quality metrics and key performance indicators (KPIs).
Identify trends, risks, and opportunities for improvement.
Develop corrective and preventive action plans where necessary.
Provide management reporting and operational insights.
Team Leadership & Development
Recruit, mentor, coach, and develop TMF professionals.
Conduct performance reviews and career development planning.
Deliver training programs related to:
TMF Management
Regulatory Compliance
Quality Standards
Inspection Readiness
Promote knowledge sharing and professional growth within the team.
Required Qualifications
Education
Required
Bachelor’s Degree in:
Life Sciences
Clinical Research
Pharmacy
Biotechnology
Healthcare
Related Scientific Discipline
Preferred
Master's Degree
Clinical Research Certification
TMF Management Certification
Advanced Qualification in Clinical Operations or Document Management
Required Experience
Extensive experience in:
Trial Master File (TMF) Management
Clinical Operations
Clinical Documentation Management
Experience working within:
Clinical Research Organizations (CROs)
Pharmaceutical Companies
Biotechnology Organizations
Proven experience managing TMF processes across multiple clinical studies.
Leadership Experience
Experience leading and managing TMF teams.
Demonstrated ability to drive operational excellence and team performance.
Experience managing stakeholder relationships across functions.
Uttar Pradesh :
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