Oversee, create, manage, and deliver the eTMF in accordance with GCP, ICH Guidelines, and
Create and execute the study TMF Plan and project TMF Document Index.
Attend project kick-off, internal/external meetings, and ensure team is aware of eTMF status and
Ensure eTMF system is updated with country, site, contact, and document requirements.
Collaborate with Project Manager and Functional Leads to ensure timely, high-quality TMF
Monitor and report TMF Health to internal team and sponsor, identifying trends and risks.

🎯 Requirements

4-year college degree or equivalent combination of education and experience, ideally in business
At least 3-4 years of experience with TMF and/or eTMF, with at least 1+ year as TMF Lead.
Established experience and fluency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
Ability to speak English proficiently (professional level).
Ideally experience using Veeva Vault to process documents.
Demonstrates solid interpersonal skills.

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