(Associate) Country Study Manager - CV
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 studies and regulatory submissions
Domain
Healthcare / Clinical Research
Required skills
Clinical study planning, team leadership, budget and timeline management, regulatory compliance, risk management, stakeholder communication, resource allocation, audit preparation, investigator coordination, document management, training and mentoring
Preferred skills
Experience with IT systems (IMPACT, ACCORD), knowledge of local study management requirements, ability to facilitate translation, process improvement
Technologies
IMPACT, ACCORD
Responsibilities
Lead local study teams and optimize performance, manage study timelines and budgets, coordinate investigator selection and meetings, prepare study documents and submissions, conduct audits and inspections, ensure compliance with ICH-GCP and local regulations, facilitate translation of study documents, manage serious adverse event reconciliation, provide regular updates to line managers
Seniority
Senior, hands-on IC