Senior TMF Specialist
Location: Chennai, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR142071
Application Deadline: February 27, 2026
Company: ICON plc
ThePharmaDaily.com is featuring an opportunity for a Senior TMF Specialist with ICON plc, a globally recognized clinical research organization (CRO) delivering healthcare intelligence and end-to-end clinical development solutions. This role is designed for experienced clinical documentation professionals with strong expertise in Trial Master File (TMF) management, regulatory compliance, and inspection readiness.
Job Overview
The Senior TMF Specialist is responsible for leading Trial Master File (TMF) oversight activities across clinical trials, ensuring completeness, accuracy, and regulatory compliance in alignment with ICH-GCP, global health authority requirements, and sponsor standards. The role focuses heavily on eTMF review, missing document identification, metadata quality checks, and maintaining inspection-ready documentation within Veeva Vault.
This position plays a critical role in supporting regulatory audits and contributing to the successful execution of global clinical development programs.
Key Responsibilities
Perform comprehensive eTMF completeness checks, including periodic and milestone reviews
Conduct cross-checks and co-dependency reviews to identify missing or inconsistent documents within Veeva Vault
Ensure allocated studies maintain continuous inspection readiness
Update and maintain the Expected Document List (EDL) as required
Perform ALCOEA and metadata quality checks to ensure document integrity and regulatory compliance
Collaborate with Study Teams and TMF Leads to gather review requirements and close action items
Proactively follow up with stakeholders to resolve documentation gaps
Deliver internal TMF-related training sessions and address team queries
Adhere to agreed service level agreements (SLAs) and stakeholder deliverables
Required Qualifications and Experience
Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related scientific field (advanced degree preferred)
Minimum 7 years of experience in TMF management and periodic review within clinical research
At least 2–3 years of hands-on experience in identifying and reconciling missing TMF documents
Strong working knowledge of Veeva Vault eTMF system
Proficiency in Microsoft Excel and document tracking tools
Thorough understanding of ICH-GCP, TMF regulations, and global regulatory guidelines
Experience with electronic document management systems (EDMS)
Excellent organizational skills, attention to detail, and communication abilities
Core Competencies
Advanced eTMF review and inspection readiness management
Regulatory compliance and documentation quality control
ALCOEA principles application
Clinical trial lifecycle documentation expertise
Stakeholder coordination and issue resolution
Compensation and Benefits
ICON offers a competitive compensation package aligned with industry standards and country-specific benefits focused on employee well-being and work-life balance. Benefits may include:
Annual leave entitlements
Comprehensive health insurance options
Retirement and financial planning programs
Global Employee Assistance Programme (TELUS Health)
Life assurance coverage
Flexible optional benefits such as childcare support, wellness initiatives, gym memberships, and travel subsidies
Equal Opportunity Statement
ICON is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive equal consideration without discrimination based on protected characteristics. Reasonable accommodations are available during the recruitment and employment process where required.
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