Manager, TMF Operations
Location: Chennai, India
Work Model: Office-Based (Office with Flex)
Job Type: Full-Time
Application Deadline: June 30, 2026
Job Requisition ID: JR143093
About ICON
ICON is a global healthcare intelligence and clinical research organization dedicated to accelerating the development of innovative medicines and therapies that improve patient outcomes worldwide.
Driven by our values of Integrity, Collaboration, Agility, and Inclusion, we empower our teams to deliver high-quality clinical research solutions while fostering professional growth and innovation.
Position Overview
We are seeking an experienced Manager, TMF Operations to lead Trial Master File (TMF) operations and ensure the quality, completeness, and regulatory compliance of TMF documentation across multiple clinical studies.
This leadership role is responsible for overseeing TMF processes, managing a team of TMF professionals, ensuring inspection readiness, driving process improvements, and collaborating with cross-functional stakeholders to support successful clinical trial execution.
The ideal candidate will possess strong expertise in TMF management, regulatory compliance, audit readiness, team leadership, and clinical trial documentation.
Key Responsibilities
TMF Operations Management
Lead and manage TMF Operations activities across multiple clinical studies.
Oversee the maintenance, quality, and completeness of Trial Master Files (TMFs).
Ensure TMFs are managed in accordance with:
ICH-GCP Guidelines
Regulatory Requirements
Sponsor Requirements
Company SOPs and Policies
Monitor TMF performance and operational effectiveness.
TMF Documentation Oversight
Supervise the collection, review, filing, and maintenance of essential clinical trial documents.
Ensure documentation is complete, accurate, and filed within required timelines.
Maintain ongoing oversight of document quality throughout the clinical trial lifecycle.
Support document reconciliation and completeness reviews.
Inspection Readiness & Compliance
Ensure Trial Master Files remain inspection-ready at all stages of study execution.
Lead preparation activities for:
Regulatory Inspections
Sponsor Audits
Internal Quality Audits
Client Reviews
Identify and resolve TMF gaps, deficiencies, and compliance risks.
Coordinate corrective and preventive actions (CAPA) when required.
Cross-Functional Collaboration
Partner with:
Clinical Operations
Regulatory Affairs
Quality Assurance
Project Management
Study Teams
Sponsors and Clients
Ensure alignment on TMF requirements and study documentation expectations.
Facilitate effective communication regarding TMF status and compliance metrics.
Process Improvement & Governance
Develop and implement TMF management strategies, procedures, and best practices.
Drive continuous improvement initiatives to enhance TMF quality and operational efficiency.
Establish and maintain TMF governance standards across projects.
Support implementation of new technologies and process enhancements.
Quality Management
Monitor and analyze TMF quality metrics and performance indicators.
Conduct quality reviews and trend analyses.
Identify opportunities for process optimization and risk reduction.
Ensure adherence to quality management standards and documentation practices.
Team Leadership & Development
Lead, mentor, and develop TMF Operations staff.
Foster a culture of quality, accountability, and continuous improvement.
Conduct performance management, coaching, and career development activities.
Provide ongoing training on TMF processes, regulatory requirements, and industry best practices.
Stakeholder & Client Management
Serve as a key point of contact for TMF-related operational matters.
Support client interactions regarding TMF status, compliance, and inspection readiness.
Build strong relationships with internal and external stakeholders.
Communicate project risks, challenges, and mitigation strategies effectively.
Required Qualifications
Education
Bachelor’s Degree in one of the following disciplines:
Life Sciences
Clinical Research
Pharmacy
Biotechnology
Healthcare Sciences
Related Scientific Field
Preferred
Master’s Degree in a related field.
Professional certifications in Clinical Research, TMF Management, Quality Management, or Regulatory Compliance.
Experience
Required
Extensive experience in TMF Management, Clinical Operations, or Clinical Trial Documentation.
Proven experience within:
Pharmaceutical Companies
Biotechnology Organizations
Clinical Research Organizations (CROs)
Demonstrated experience managing TMF teams and clinical documentation processes.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Wavre |Tipperary :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
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Canada |Quebec :
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Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
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