Trial Master File (TMF) Manager

Role: TMF (Trial Master File) Manager overseeing clinical documentation processes, systems, and compliance for Phase I–IV studies within BioCryst's clinical operations. Responsibilities: develop and implement TMF strategies, manage electronic systems (e.g., Veeva Vault), ensure regulatory compliance, oversee audits/inspections, and coordinate cross-functional collaboration to maintain inspection-ready TMFs. Requirements: Bachelor’s degree, 7–10 years in clinical research or pharma, with 5+ years direct TMF/eTMF experience; proficiency with Veeva Vault and DIA TMF Reference Model; knowledge of GCP/ICH guidelines; experience in audits, vendor oversight, and process improvement. High-Value: extensive TMF system expertise, clinical trial documentation, GCP compliance, cross-functional stakeholder engagement in a regulated environment. Location: likely hybrid, with responsibilities spanning global multicenter trials, no travel specified.