Sr. TMF Specialist (Contractor)
About the role
This position is responsible for collecting, reviewing, maintaining, and archiving essential Regulatory documents for the Trial Master File (TMF) 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 Arcus Standard Operating Procedures (SOPs) as appropriate. The Senior Clinical Document Specialist will provide support to the TMF content owners on one or more clinical programs. This position will work closely with the Study Management Teams (SMT) to ensure that the TMF is kept both current and inspection ready according to Arcus SOPs and applicable regulations. This is a 6 month full time contract, remote US.
Responsibilities
- Work directly with TMF Content Owners to identify issues, perform completeness checks, and upload documents to the eTMF
- Acting as TMF subject matter expert (SME)/point of contact for study teams and TMF stakeholders, including attending study team meetings and managing EDLs
- Review and classify documents collected from internal and external sources
- Reconcile essential documents to avoid duplication
- Support study teams with the TMF quality review process