Job Opportunity: Senior TMF Specialist – ICON plc
Job Summary:
ICON plc is seeking a detail-oriented and experienced Senior TMF Specialist to join our team in Chennai, India. This role is pivotal in ensuring that our clinical trial documentation remains accurate, compliant, and inspection-ready throughout the entire lifecycle of a study. The ideal candidate will possess deep expertise in eTMF systems, particularly Veeva Vault, and a strong understanding of regulatory standards, ALCOEA principles, and clinical operations. You will play a key role in maintaining the integrity of our global clinical trials and supporting our mission to accelerate medical breakthroughs.
Key Responsibilities
As a Senior TMF Specialist, you will be responsible for the end-to-end management of clinical documentation. Your core duties will include:
- Documentation Management: Perform comprehensive eTMF completeness checks and milestone reviews to ensure all required documentation is accurately captured.
- Compliance & Quality Assurance: Conduct ALCOEA (Attributable, Legible, Contemporaneous, Original, Accurate) compliance checks and verify metadata to ensure the TMF is always audit-ready.
- eTMF Oversight: Utilize Veeva Vault to identify and track missing documentation, manage the Expected Document List (EDL), and perform cross-dependency checks.
- Collaborative Support: Act as a primary point of contact for study teams and TMF Leads, providing guidance on documentation requirements and best practices.
- Process Improvement: Provide training to internal teams regarding TMF processes and documentation standards.
- Action Tracking: Proactively follow up on missing documents and ensure all TMF-related action items are closed within established Service Level Agreements (SLAs).
Required Qualifications
To be successful in this role, candidates must meet the following criteria:
- Education: A Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related scientific discipline is required. An advanced degree is considered a significant advantage.
- Experience: A minimum of 4–5 years of professional experience in Trial Master File (TMF) management, with at least 2–3 years specifically focused on identifying missing documents within an eTMF system.
- Technical Proficiency: Strong working knowledge of electronic document management systems, with specific experience in Veeva Vault. Proficiency in Microsoft Excel is essential.
- Regulatory Knowledge: Solid understanding of TMF regulations, clinical trial documentation standards, ICH-GCP guidelines, and the TMF reference model.
- Soft Skills: Exceptional organizational and communication skills, with a high degree of attention to detail and the ability to work effectively within global, cross-functional teams.
Benefits and Compensation
At ICON plc, we value our employees and offer a professional environment that fosters career development and growth.
- Competitive Salary: Annual CTC ranging from ₹10,00,000 to ₹16,00,000, commensurate with experience.
- Career Growth: Opportunities to work on international clinical trials and advance into leadership roles within clinical operations.
- Supportive Environment: Comprehensive health insurance coverage and performance-based bonuses.
- Global Exposure: The opportunity to work with one of the world’s leading clinical research organizations, gaining exposure to complex, global regulatory projects.
Job Location
This position is based in Chennai, Tamil Nadu, India. You will be part of a dynamic, global workforce dedicated to healthcare intelligence.
How to Apply
If you are a motivated professional looking to make a significant impact in clinical research, we encourage you to apply.
[Click here to submit your application and view the full job listing via the official ICON plc portal.]
ICON plc is an equal opportunity employer committed to fostering an inclusive workplace. We look forward to reviewing your application.