Senior TMF Specialist - Hayward, CA
2 weeks ago
Job Summary
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 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 applicable regulations
Responsibilities Including But Not Limited To Work directly with TMF Content Owners to identify issues perform completeness checks 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 managing EDLs Review classify document collected from internal external sources Reconcile essential documents avoid duplication Support study teams with the quality review process Perform QC maintenance of eTMFs assigned studies Perform data entry reconciliation in various clinical systems tracking tools Provide input revision of related Work Instructions SOPs Support management oversight CROstudy specific trial master files Coordinate transfer study specific trial master files from CRO Follow up on quality findings Manage paper filing process wet signed documents QC review paper electronic filing Participation audit inspection readiness preparation activities as needed Work cross functionally internal departments external resources eg CRO Partners etc resolve gaps in ETMFPossibly require occasional travel May provide training mentoring new staff Develop metrics reports TMs tools trainings Act standin leading team meeting managing task needs Position may require occasional travel
Job description
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