Position Title: Senior TMF Specialist
Job ID: JR132671
Location: Chennai, India (Hybrid – Office-Based)
Department: Regulatory Document Management
Recruiter: Amrutha Saidala
🔗 Apply Now via ICON Careers
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research. We drive innovation and excellence by fostering an inclusive, collaborative environment. Join us in shaping the future of clinical development through meaningful work that supports groundbreaking medical advancements.
Role Summary
As a Senior TMF Specialist, you will play a critical role in managing the Trial Master File (TMF) for clinical trials, ensuring regulatory compliance, completeness, and inspection readiness. This role requires strong document knowledge, expertise in eTMF systems, and attention to detail.
Key Responsibilities
Perform completeness reviews and periodic/milestone checks on the eTMF using Veeva Vault.
Conduct cross-checks and co-dependency reviews to identify missing or non-compliant documents.
Ensure inspection readiness for assigned studies by maintaining TMF quality and compliance.
Update and maintain the Expected Document List (EDL) as needed.
Execute ALCOEA checks and validate document metadata for accuracy.
Collaborate with the study team and TMF Lead to gather review requirements and follow up on action items.
Conduct internal training sessions to support team understanding and address TMF-related queries.
Ensure deliverables are met as per Service Level Agreements (SLAs) and timelines agreed upon with stakeholders.
Candidate Requirements
Education:
Bachelor's degree in Life Sciences, Pharmacy, or a related field (Master’s degree preferred).
Experience:
Minimum 7 years of experience in TMF management and periodic reviews.
At least 2–3 years of experience specifically focused on missing document identification.
Strong working knowledge of Veeva Vault and Microsoft Excel (preferred).
Skills:
Solid understanding of TMF regulations, ICH-GCP guidelines, and industry best practices.
Proficiency in electronic document management systems (e.g., Veeva Vault).
Excellent attention to detail, organizational, and communication skills.
What ICON Can Offer You
ICON provides a rewarding, flexible, and growth-oriented work environment. In addition to a competitive salary, we offer a comprehensive benefits package tailored to support your personal and professional life.
Examples of Benefits Include:
Competitive annual leave entitlements
Variety of health insurance plans for employees and families
Retirement planning options for financial security
Access to LifeWorks – Global Employee Assistance Programme with 24/7 professional mental health and well-being support
Life assurance coverage
Flexible, country-specific optional benefits such as:
Childcare vouchers
Bike-to-work schemes
Discounted gym memberships
Subsidised travel passes
Health assessments
Diversity & Inclusion at ICON
At ICON, inclusion and belonging are central to our mission. We are proud to be an equal opportunity employer, committed to building a discrimination- and harassment-free workplace.
All qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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