TMF/eTMF Program Manager – Inspection-Ready Oversight

BioCryst Pharmaceuticals, Inc.; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks a Trial Master File (TMF) Manager to lead TMF/eTMF processes across Phase I–IV studies. You will own Veeva/CTMS workflows, SOP development, and archival practices, ensuring inspection readiness and regulatory submissions.

You will partner with study teams, CROs, and IT to maintain high-quality TMFs, generate dashboards, and support audits and inspections, while training staff on TMF standards and filing guidance.

Qualifications

• Bachelor’s degree with 7–10 years in clinical research or pharmaceutical industry, incl. 5+ years TMF/eTMF.
• Hands-on experience with DIA TMF Reference Model and Veeva Vault Clinical.
• Knowledge of GCP/ICH guidelines and audit readiness.

Responsibilities

• Act as the TMF SME; lead eTMF, CTMS processes, SOPs, and training materials.
• Develop, deploy, maintain, and improve TMF/eTMF filing, indexing, and archival.
• Establish dashboards and reports for study visibility by country and site.
• Coordinate with CROs, system admins, and QA for inspections and actions.
• Support audits/regulatory inspections and provide TMF training.

Skills

TMF/eTMF experience

Veeva Vault Clinical

CTMS

GCP/ICH knowledge

CRO oversight

Training & process improvement

Education

Bachelor’s degree in life sciences or related

Tools

DIA TMF Reference Model

MS Office / Databases

Job description

BioCryst Pharmaceuticals, Inc. seeks a Trial Master File (TMF) Manager to lead TMF/eTMF processes across Phase I–IV studies. You will own Veeva/CTMS workflows, SOP development, and archival practices, ensuring inspection readiness and regulatory submissions.

You will partner with study teams, CROs, and IT to maintain high-quality TMFs, generate dashboards, and support audits and inspections, while training staff on TMF standards and filing guidance.