Senior TMF Specialist – ICON plc
Location: Chennai, India
Job ID: JR132671
Department: Regulatory Document Management – Full Service & Corporate Support
Work Mode: Hybrid – Office-Based
About ICON plc
ICON plc is a global leader in healthcare intelligence and clinical research, delivering innovative solutions that advance clinical development and patient outcomes. Our inclusive culture fosters collaboration, excellence, and innovation, empowering professionals to contribute to cutting-edge clinical trials worldwide.
Role Overview
ICON is seeking a Senior TMF Specialist to manage and maintain the Trial Master File (TMF) for clinical studies, ensuring compliance with global regulatory standards. The successful candidate will play a critical role in maintaining inspection-ready TMFs, supporting study teams in achieving operational excellence and advancing clinical research initiatives.
This role is ideal for candidates with extensive TMF experience, proficiency in electronic document management systems (EDMS), and expertise in Veeva Vault.
Key Responsibilities
Conduct comprehensive eTMF completeness checks, periodic reviews, and milestone assessments to identify missing or incomplete documents.
Ensure allocated eTMFs are inspection-ready and compliant with global regulatory requirements.
Perform cross-checks, co-dependency checks, and metadata validation (ALCOA+) to ensure data accuracy and completeness.
Update and maintain the Expected Document List (EDL) as needed for assigned studies.
Collaborate with study teams and TMF Leads to collect initial requirements and resolve document-related queries.
Track, follow up, and close outstanding TMF action items efficiently.
Conduct training sessions for internal teams on TMF processes and ensure timely resolution of queries.
Adhere to standard SLAs and deliverables agreed upon with stakeholders.
Required Qualifications & Experience
Bachelor’s degree in a scientific, life sciences, or related field; advanced degree preferred.
7+ years of TMF experience, including periodic and milestone reviews.
2–3 years of experience identifying missing documents within TMFs.
Hands-on experience with Veeva Vault and strong Excel proficiency is highly desirable.
Deep understanding of TMF regulations, guidelines, and industry best practices.
Proficiency in electronic document management systems (EDMS) and TMF software.
Strong organizational, communication, and attention-to-detail skills.
Ability to work independently and collaborate effectively with cross-functional teams.
What ICON Offers
ICON is committed to fostering a diverse culture, professional growth, and employee well-being. Key benefits include:
Competitive salary and annual leave entitlements.
Comprehensive health insurance packages for employees and families.
Retirement planning options to maximize long-term financial security.
Access to LifeWorks, a 24/7 Global Employee Assistance Programme.
Life assurance and flexible country-specific benefits, including childcare support, gym discounts, subsidized travel, and health assessments.
Diversity & Inclusion
ICON ensures an inclusive and accessible workplace for all candidates. Equal consideration is provided regardless of race, gender, religion, disability, or other protected characteristics. Reasonable accommodations are available upon request.
Application Guidance
Candidates who meet most, but not all, requirements are encouraged to apply.
Current ICON employees should apply through internal portals.
Submit a detailed resume for full consideration.
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