Director, Country Operations Management
Core
Lead local execution team for clinical trial programs, ensuring high-quality, timely, and cost-effective delivery of study deliverables in accordance with local regulations and ICH/GCP guidelines.
Role type
Senior Director, Country Operations Management (Clinical Trials)
Builds
Clinical trial programs (site selection, start-up, enrollment, data deliverables, close-out) for assigned programs
Domain
Biotechnology / Clinical Research / Rare Diseases
Required skills
Clinical operations management, team leadership and development, vendor management (CROs), regulatory compliance (ICH/GCP), budgeting and resource optimization, stakeholder management, project management, risk management, data-driven planning
Preferred skills
Field CRA experience, ultra-rare disease study experience, adult and pediatric clinical research experience, Masters or Doctoral degree in a scientific discipline
Technologies
eTMF, clinical trial management systems, reporting tools
Responsibilities
Lead local execution team for assigned programs, manage vendor relationships including CROs, oversee site selection and study start-up, ensure compliance with SOPs and local regulations, develop and coach direct reports, monitor KPIs and study metrics, manage cross-functional collaboration with global and local teams, drive continuous improvement initiatives
Seniority
Director, hands-on IC with strategic oversight