(Associate) 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 regulatory submissions.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical study operations and regulatory submissions for specific countries
Domain
Life Sciences / Clinical Research
Deliverable
physical/clinical work
Required skills
Clinical study management, local regulatory compliance, team leadership, risk management, budget forecasting, investigator coordination, audit preparation, SAE reconciliation, document translation coordination
Preferred skills
Experience with IMPACT/ACCORD systems, mentoring staff, process improvement
Technologies
IMPACT, ACCORD
Responsibilities
Plan and lead study delivery from specifications to closeout; manage local study teams and optimize performance; coordinate investigator selection and recruitment strategies; prepare and submit regulatory documents (SMA, fSMA, Master CSA); manage study budgets, timelines, and resources; lead audit and inspection activities; ensure local SAE reconciliation and document archiving.
Seniority
Senior, hands-on IC
