Senior TMF Specialist – ICON plc
Location: Chennai, India
Job ID: JR132671
Portfolio: Full Service & Corporate Support – Regulatory Document Management
Work Type: Hybrid / Office-Based
Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.
Role Overview
The Senior TMF Specialist is responsible for managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements, and supporting the inspection readiness of allocated studies. The role involves document review, collaboration with study teams, and providing guidance to internal staff on TMF processes.
Key Responsibilities
Perform comprehensive eTMF completeness checks, periodic or milestone reviews, including cross checks and co-dependency checks to identify missing documents in Veeva Vault.
Ensure eTMF is inspection-ready for assigned studies.
Conduct completeness checks and update the Expected Document List (EDL) as required.
Identify missing documents and ensure ALCOA-E and metadata compliance.
Collaborate with study teams and TMF Leads to collect initial requirements for review.
Follow up with study teams to close action items.
Conduct training for internal teams and address team queries.
Follow standard SLAs and ensure deliverables meet agreements with stakeholders.
Required Education & Skills
Bachelor’s degree in a scientific or related field; advanced degree preferred.
Minimum 7 years of experience in TMF and periodic review.
2–3 years’ experience identifying missing documents.
Experience with Veeva Vault and strong Excel skills are advantageous.
Strong understanding of TMF regulations, guidelines, and best practices.
Proficiency in electronic document management systems and TMF software.
Excellent organizational, communication, and attention to detail skills.
Benefits
ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:
Annual leave entitlements
Health insurance options for employees and families
Competitive retirement planning offerings
Global Employee Assistance Programme (LifeWorks, 24/7 access to specialized professionals)
Life assurance
Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)
More details: ICON Careers Benefits
Diversity & Inclusion
ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Reasonable accommodations are available: Request here
Application Encouragement
Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.
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