Clinical Operations Associate Director

Job Summary

Leading the monitoring strategy for clinical trials, the full-time remote Clinical Operations Associate Director will provide expertise in GCP and clinical operations, manage Site and Monitoring Health Regional Leads, and ensure effective oversight of CRO monitoring activities.

Key responsibilities:

• Develop and implement the Site and Monitoring Health strategy in alignment with ICH GCP guidelines
• Lead and support regional leads in assessing CRO monitoring effectiveness across clinical trial portfolios
• Manage day-to-day activities of Vendor Site and Monitoring Health Leads while ensuring compliance with oversight plans

Required qualifications:

• Bachelor's degree required; advanced clinical degree (e.g., RN, MPH, MS, MA, MBA, PharmD) preferred
• Previous experience in Sponsor Oversight and Site and Monitoring Health, with line management experience preferred
• Solid direct monitoring experience with a CRO or pharmaceutical company on multinational clinical studies
• Experience in all phases of clinical research (Phase I-IV) and familiarity with rare medical conditions preferred
• Comprehensive knowledge of regulatory standards, including GCPs