Senior TMF Specialist - India, Chennai - Office Based - 5+ years of TMF experience; must include 2+ years of experience in periodic file review with co-dependency checks, cross checks and identification of missing documents.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Senior TMF Specialist to join our diverse and agile team. As a Senior TMF Specialist at ICON, you will play a pivotal role in managing the Trial Master File (TMF) for clinical trials, ensuring compliance with regulatory requirements and contributing to the advancement of innovative treatments and therapies.

What you will be doing:
- Perform a comprehensive eTMF completeness check/ periodic or milestone review and focus on cross checks, co-dependency checks and identify missing documents in Veeva Vault.




- Ensure eTMF is inspection ready for allocated studies.
- Conduct completeness check and update the expected document list (EDL) as on when required.
- Candidate would have good document knowledge to identify missing documents.
- Perform ALCOEA and metadata check to ensure accuracy and compliance.
- Collaborate with study team and TMF Lead to collect the initial requirements for review.
- Follow-up with study team and close the action items.
- Conduct training for internal team and ensure team queries are addressed.
- Follow standard SLA and deliverables are meet as per agreement with the stakeholders.

Your profile:
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 5 years of experience in TMF and periodic review.
- Must have 2-3 years’ experience which involves codependency checks, cross checks and identification of missing documents.
- Having

📌 Senior TMF Specialist (Chennai)
🏢 IRE
📍 Chennai