TMF Documentation Coordinator

Job Summary:

• The primary purpose of this job is to file, QC, and remediate Medical Writing documentation required for Trial Master Files.

• Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation.

• Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfilled documentation; performing periodic review and remediation of TMF.