TMF Lead I

📋 Description

• Ensure that TMF document review and processing, periodic quality review, set up, maintenance
• Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team
• Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is
• Attend and contribute to project kick-off meetings, project internal or external meetings, and ad
• Engage and collaborate with the Project Manager and Functional Leads to ensure TMF documentation is
• Proactively anticipate challenges to TMF compliance and identify early signals of risk. Develop and

🎯 Requirements

• Bachelor’s degree (or its international equivalent) +5 years of related experience or equivalent
• Working knowledge of FDA & ICH/GCP regulations and guidelines
• Demonstrates solid interpersonal skills
• Ability to identify issues and escalate appropriately and effectively
• Excellent organizational skills, time management, and ability to coordinate workload and meet
• Manage competing priorities effectively