Associate Director, TMF Operations Lead

📋 Description

• Lead TMF ops across clinical studies to ensure inspection-ready TMF per ICH-GCP.
• Establish TMF governance; monitor TMF health, quality metrics, readiness.
• Develop and maintain TMF processes and documents: Plans, Indexes, SOPs, CRO oversight plans.
• Partner with Clinical Ops, Regulatory, Data Mgmt, Medical Writing, QA and vendors to file docs and resolve issues.
• Oversee CRO TMF activities via metrics, governance meetings, QA reviews, CAPA follow-up.
• Lead TMF inspection readiness activities: audits, artifact retrieval, CAPA development.

🎯 Requirements

• 8+ years in TMF Ops/Clinical Ops/Clinical Quality with global trials; university degree or equivalent.
• Understanding of the drug development life cycle.
• Experience handling clinical trial documents and TMF activities.
• Strong knowledge of TMF Reference Model Structure and country-level documents.
• ALCOA+ standards, ICH-GCP, and Good Documentation Practices.
• Proficient with Excel/Word/PowerPoint; Smartsheet and SharePoint.

🎁 Benefits

• Market-leading compensation
• 401(k) with employer match
• Pre-tax commuter benefits
• Flexible paid time off and holidays
• Comprehensive medical, dental, and vision coverage; parental leave
• Hybrid work model with flexibility