Senior TMF Operations Leader (Remote) – Veeva Vault Expert

Kyverna Therapeutics; United States; Teletrabalho; USD 180 000 - 240 000; Tempo integral

Resumo da oferta

Scorpion Therapeutics seeks an Associate Director, TMF Lead to develop and execute Kyverna's in-house Trial Master File strategy, ensuring inspection readiness and regulatory compliance across clinical studies.

The role oversees TMF governance, document quality, and lifecycle, while leading migrations and vendor assessments with close collaboration across Clinical Operations, Regulatory, Quality and IT. Remote eligible with reporting to Sr. Director, Clinical Operations.

Qualificações

• 10+ years in clinical research with extensive TMF expertise.
• Deep knowledge of TMF structures and regulatory standards (FDA, EMA, ICH-GCP).
• Proven experience with TMF migrations and in-house transition strategies.

Responsabilidades

• Lead end-to-end TMF setup and governance.
• Oversee TMF document quality and lifecycle from start-up to close-out.
• Lead TMF migration efforts and evaluate TMF system vendors (notably Veeva Vault).
• Support regulatory audits and collaborate with Clinical Operations, Regulatory, Quality, and IT.

Conhecimentos

TMF governance

Regulatory compliance

Cross-functional leadership

Vendor management

Collaboration with cross functional

Formação académica

Bachelor's degree in life sciences or related field

Ferramentas

Veeva Vault

Descrição da oferta de emprego

Scorpion Therapeutics seeks an Associate Director, TMF Lead to develop and execute Kyverna's in-house Trial Master File strategy, ensuring inspection readiness and regulatory compliance across clinical studies.

The role oversees TMF governance, document quality, and lifecycle, while leading migrations and vendor assessments with close collaboration across Clinical Operations, Regulatory, Quality and IT. Remote eligible with reporting to Sr. Director, Clinical Operations.