TMF Lead – Trial Master File Management & Clinical Documentation Oversight
Location: Chennai / Bangalore, India
Job Type: Full-Time | Office with Flex
Company: ICON plc
Job ID: JR146282
Application Deadline: April 30, 2026
About the Role
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced TMF Lead to oversee end-to-end Trial Master File (TMF) management across clinical trials. This leadership role is responsible for ensuring TMF completeness, inspection readiness, and compliance with global regulatory standards throughout the clinical trial lifecycle.
You will collaborate with cross-functional stakeholders, manage TMF quality, and drive best practices in clinical documentation to support efficient and compliant study execution.
Key Responsibilities
Lead TMF setup, maintenance, and oversight across the full clinical trial lifecycle (start-up to archival)
Ensure TMF compliance with regulatory requirements, ICH-GCP guidelines, and internal SOPs
Collaborate with cross-functional teams to ensure timely and accurate document filing
Conduct TMF quality reviews, audits, and completeness checks to identify and resolve issues
Manage Expected Document Lists (EDL), TMF metrics, and document tracking processes
Ensure TMF inspection readiness for audits and regulatory inspections
Lead client-facing interactions, study meetings, and stakeholder communications
Provide training, mentorship, and guidance to TMF team members
Drive continuous improvement initiatives in TMF processes and documentation practices
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Nursing, Business Administration, or a related field (advanced degree preferred)
Minimum 8+ years of TMF experience with full lifecycle exposure (start-up, maintenance, archival)
Strong experience in client management, project management, and stakeholder engagement
Hands-on expertise in Veeva Vault eTMF, including EDL management, quality checks, and metrics tracking
Proven experience in audit readiness and managing client/regulatory inspections
In-depth understanding of TMF regulations, compliance standards, and clinical documentation practices
Excellent communication, leadership, and organizational skills
Willingness to relocate to Chennai or Bangalore
Preferred Skills
Experience in global, multi-study clinical trial environments
Strong analytical and problem-solving capabilities
Ability to lead teams and manage complex documentation workflows
Why Join ICON
ICON offers a collaborative and high-performance environment where TMF leaders contribute to regulatory excellence and clinical trial success on a global scale.
Key Benefits Include
Competitive salary and leadership career opportunities
Flexible work environment (office with flexibility)
Generous leave policies
Comprehensive health insurance
Retirement and financial planning benefits
Global Employee Assistance Programme (24/7 support)
Life insurance and wellness programs
Flexible, country-specific employee benefits
Diversity, Equity & Inclusion
ICON is committed to building an inclusive workplace where all qualified applicants receive equal opportunity without discrimination.
Application Note
Candidates who may not meet all requirements are encouraged to apply. ICON values diverse experience and supports continuous professional growth.
This role is ideal for senior TMF professionals seeking leadership opportunities in clinical documentation, regulatory compliance, and global trial management within a leading CRO.
Uttar Pradesh :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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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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Hamburg |Rhineland Palatinate :
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Saarbrucken |Switzerland :
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Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
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Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
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Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Japan | Saitama |Tokyo :
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