Ensure TMF documents are reviewed, quality-checked, maintained, archived.
Create TMF Plan and TMF Index; ensure team understands TMF.
File TMF documentation in the system and update as needed.
Attend kick-offs/meetings to discuss TMF status and gaps.
Collaborate with PM/Leads to ensure timely, quality TMF submissions for inspections.
Identify TMF risks and monitor health; escalate to leadership.

🎯 Requirements

Bachelor's degree (or international equivalent) and 3+ years related experience.
Professional working proficiency in English.
Experience with eTMF systems and vendors.
Working knowledge of FDA and ICH-GCP regulations.
MS Office proficiency (Outlook, Word, Excel, PowerPoint).
Strong interpersonal skills and ability to work independently or in a team.

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