(Associate) Country Study Manager - CVRM
Core
Planning and leading clinical study delivery from specifications to closeout, managing local study teams, and ensuring compliance with regulations and quality standards.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical study operations and regulatory submissions for AstraZeneca
Domain
Biopharmaceuticals / Clinical Operations
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study planning, team leadership, regulatory compliance, budget forecasting, risk management, stakeholder negotiation, audit preparation, investigator coordination, document management, training delivery
Preferred skills
Experience with IMPACT/ACCORD systems, knowledge of local study management requirements, ability to facilitate translation services
Technologies
IMPACT, ACCORD
Responsibilities
Lead local study teams and optimize performance, manage study timelines and budgets, coordinate investigator selection and meetings, prepare regulatory submissions and country study master files, conduct audits and inspections, ensure SAE reconciliation and drug consumption planning
Seniority
Senior, hands-on IC
