TMF Lead/Senior TMF Lead

Precision for Medicine is hiring an experienced TMF Lead/Senior TMF lead to join our team, candidates can work remotely in Serbia, Poland, Hungary, Romania or Slovakia.

 

The TMF Lead/Senior TMF Lead is responsible for oversight, creation, management, and delivery of the eTMF in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, relevant regulations (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives), and Precision Standard Operating Procedures (SOPs) as appropriate. The Senior TMF Lead may take on responsibility for the complex and/or challenging studies. Additionally, the Senior TMF lead supports the development and implementation of TMF-related processes and systems.

 

Essential Functions of the job include but are not limited to:

· Creates and executes the study TMF Plan and project TMF Document Index. Ensures entire study team understands expectations, project-specific aspects of t... Click Apply to read the full job description.