(Associate) Country Study Manager - R&I
Core
Plan, lead, and deliver clinical studies from specifications 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 deliverables including protocols, monitoring plans, regulatory submissions (CSRs, annual reports), and Study Master Files for specific countries.
Domain
Healthcare / Clinical Research / Pharmaceutical
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study planning and execution, local regulatory compliance (ICH-GCP), local study team leadership, investigator recruitment and coordination, budget and timeline management, audit and inspection preparation, risk management, document preparation and archiving.
Preferred skills
Experience with IT systems (IMPACT, ACCORD), mentoring and competency development, negotiation with external service providers, translation coordination.
Technologies
IMPACT, ACCORD
Responsibilities
Lead Local Study Team(s) and optimize performance; coordinate investigator selection and national Investigator meetings; manage study timelines, budgets, and resources; prepare country-specific regulatory documents (SMA, fSMA, Master CSA); facilitate translation of study documents; ensure timely submission to EC/IRB and Regulatory Authorities; manage SAE reconciliation and drug consumption plans.
Seniority
Senior, hands-on IC
