Performs periodic TMF Quality Reviews for assigned projects in a timely, high-quality manner.
Ensures TMF documentation for reviews is generated and filed in the TMF.
Informs the TMF Lead if TMF is not updated with country/site/contact info and requirements.
Monitors and escalates TMF processing issues to the TMF Lead, incl. missing docs.
Supports updates to expected documents and placeholders during reviews.
Identifies training needs to maintain high quality TMF maintenance.

🎯 Requirements

Bachelor’s degree (or international equivalent) + 2 years related experience.
Microsoft Office: Outlook, Word, Excel, PowerPoint
Experience with eTMF systems and vendors
Working knowledge of FDA & ICH/GCP regulations and guidelines
Demonstrates interpersonal skills
Ability to identify issues and escalate; strong organizational skills and time management

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