Performs periodic TMF Quality Reviews for assigned projects.
Ensures TMF documentation related to periodic Reviews is generated and filed in the TMF.
Informs TMF Lead if the TMF is not updated with country, site, contacts.
Monitors and escalates TMF document processing issues to the TMF Lead.
Supports updates to documents and placeholders in TMF during reviews.
Identifies training needs to improve TMF quality.

🎯 Requirements

Bachelor's degree plus 2 years related experience
Experience with MS Office: Outlook, Word, Excel, PowerPoint
Experience with eTMF systems and vendors
FDA & ICH/GCP regulations knowledge
Strong interpersonal and time-management skills
Ability to work independently and as part of a team

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