TMF/eTMF Program Lead - Veeva Vault & Inspection Readiness

BioCryst Pharmaceuticals, Inc.; North Carolina; Hybrid; USD 90,000 - 150,000; Full time

Job summary

BioCryst Pharmaceuticals, Inc. seeks a TMF Manager to lead and oversee TMF/eTMF strategies, ensuring high-quality, inspection-ready documentation across Phase I–IV studies.

You will drive standardization of TMF/indexing, and collaborate with CRA, CROs, and IT on system configurations and training. Ideal candidates have 5+ years TMF/eTMF experience, familiarity with DIA TMF Reference Model and Veeva Vault Clinical, and strong regulatory knowledge.

Qualifications

• Bachelor’s degree with 7–10 years in clinical research/pharma, including 5+ years TMF/eTMF experience.
• Hands-on with DIA TMF Reference Model and Veeva Vault Clinical (eTMF/CTMS).
• Experience with audits, regulatory inspections, CRO oversight, system implementations, training.

Responsibilities

• Act as TMF SME and process owner for eTMF, CTMS, Essential Documents.
• Lead deployment and improvement of TMF processes, SOPs, training, and filing guidance.
• Maintain TMF indices, study dashboards, and regulatory-ready archives.
• Support audits/inspections and multicenter global trials.

Skills

TMF management

eTMF systems

Veeva Vault Clinical

CTMS

GCP/ICH knowledge

Regulatory inspections

Education

Bachelor's degree

Tools

Veeva Vault Clinical

CTMS

Job description

BioCryst Pharmaceuticals, Inc. seeks a TMF Manager to lead and oversee TMF/eTMF strategies, ensuring high-quality, inspection-ready documentation across Phase I–IV studies.

You will drive standardization of TMF/indexing, and collaborate with CRA, CROs, and IT on system configurations and training. Ideal candidates have 5+ years TMF/eTMF experience, familiarity with DIA TMF Reference Model and Veeva Vault Clinical, and strong regulatory knowledge.