Senior TMF Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior TMF Specialist to join our diverse and dynamic 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 7 years of experience in TMF and periodic review.
   

• Should have 2-3 years’ experience which involves in the missing documents identification.
   

• Having Veeva Vault experience and excel knowledge is added advantage.

• Strong understanding of TMF regulations, guidelines, and best practices.

• Proficiency in electronic document management systems and TMF software.

• Excellent organizational, communication, and attention to detail skills.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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