(Sr.) Country Study Manager - CVRM
Core
Lead the end-to-end delivery of clinical studies from planning through closeout, ensuring compliance with local regulations and ICH-GCP standards while managing local study teams and investigators.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical study operations and regulatory submissions for specific countries
Domain
Life Sciences / Clinical Research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, local regulatory compliance, investigator relations, team leadership, risk management, budget forecasting, audit preparation, document management, patient recruitment strategy, training coordination
Preferred skills
Experience with IMPACT/ACCORD systems, knowledge of local healthcare policies, ability to facilitate document translation
Technologies
IMPACT, ACCORD
Responsibilities
Plan and lead study delivery from specifications to closeout; manage local study teams and investigators; coordinate regulatory submissions and inspections; oversee budget, timelines, and resource allocation; ensure compliance with local laws and ICH-GCP; facilitate document translation and site selection.
Seniority
Senior, hands-on IC
