TMF Lead II (LATAM)

Precision Medicine Group

Brazil, Mexico

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for an experienced Trial Master File TMF Lead II to help build the foundation of this new regional function in LATAM! Our TMF Lead II is responsible for supporting project teams in maintaining a high quality Trial Master Files in accordance with Good Clinical Practice (GCP), other guidance documents, and Precision Standard Operating Procedures (SOPs). The TMF Lead II supports a range of studies across the Precision Medicine Group portfolio. 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 level of 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 contribute to project kick-off meetings, project internal or external mee

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