(Sr.) Country Study Manager - CVRM
Core
Lead the end-to-end delivery of clinical studies within a specific country, managing local study teams, investigators, and regulatory submissions to ensure timely, compliant, and high-quality data delivery.
Role type
Senior Clinical Operations Manager (Country Study Leader)
Builds
Country-level clinical study operations and regulatory submissions
Domain
Pharmaceutical R&D / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study planning and execution, local study team leadership, investigator selection and management, regulatory submission coordination, budget and resource forecasting, risk management, audit and inspection preparation, training and mentoring, cross-functional collaboration
Preferred skills
Experience with targeted monitoring strategies, knowledge of local regulatory environments, ability to facilitate document translation, process improvement
Technologies
IMPACT, ACCORD
Responsibilities
Form and lead local study teams (monitors, administrators), coordinate investigator meetings and site selection, manage study timelines and budgets, prepare country-specific study master files and submissions, ensure compliance with ICH-GCP and local regulations, handle serious adverse event reconciliation, facilitate document translation, and report progress to senior management.
Seniority
Senior, hands-on IC with team leadership
