Director, Country Operations Management
Core
Lead local execution team and ensure high-quality, timely delivery of all clinical study deliverables for assigned programs in the country, adhering to local regulations and ICH/GCP guidelines.
Role type
Senior Country Operations Director (Clinical Trials)
Builds
Clinical trial programs (site selection, start-up, enrollment, data deliverables, close-out) for pharmaceutical/biotech clients
Domain
Clinical Research / Biotechnology / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical operations management, team leadership and development, vendor management (CROs), regulatory compliance (ICH/GCP), project management, budgeting, stakeholder management, risk management, process optimization, rare disease landscape knowledge
Preferred skills
Field CRA experience, ultra-rare disease study experience, adult and pediatric clinical research experience, Masters or Doctoral degree in scientific discipline
Technologies
eTMF systems, clinical trial management tools
Responsibilities
Lead local execution team for assigned programs; Direct country execution team to achieve quality and timeliness of study deliverables; Manage and develop direct reports including performance reviews and succession planning; Oversee vendor management and communication with local stakeholders (Medical Affairs, Legal); Ensure compliance with SOPs and manage inspection readiness; Approve site selections and oversee IRB/Ethics Committee interactions; Monitor KPIs and drive continuous improvement across studies.
Seniority
Director, hands-on IC with team management
