TMF Lead I

Job Summary and Purpose:

TMF Lead is responsible for supporting project teams in maintaining a high quality TMF in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). Senior TMF Lead takes on responsibility for the complex or challenging studies requiring an experienced TMF Lead. Additionally, the Senior TMF Lead supports and mentors more inexperienced TMF Leads. 

Main Duties & Responsibilities:

• Ensure that TMF document review and processing, periodic quality review, set up, maintenance, finalization and archival of study TMFs is completed in a timely manner and with a high quality.
• Create and execute the study TMF Plan and project TMF Document Index. Ensure entire study team understands expectations, project-specific aspects of the TMF, and manage communication of any changes in the TMF Plan or Index to the project team.
• Ensure that TMF documentation (e.g. TMF Plan, TMF Index, Periodic Quality Review documentation) is filed in the TMF.
• Attend and contribu... Click Apply to read the full job description.