(Associate) Country Study Manager - Rare Disease
Core
Planning and leading clinical study delivery for rare diseases from study specifications through closeout, managing local study teams, and ensuring compliance with regulations.
Role type
Senior Clinical Study Manager (Country Level)
Builds
Clinical studies for rare disease indications
Domain
Healthcare / Clinical Operations / Rare Diseases
Required skills
Clinical study planning, team leadership, regulatory compliance, budget management, risk management, stakeholder communication, resource forecasting, audit preparation, investigator coordination, document management, training and mentoring
Preferred skills
Experience with IT systems (IMPACT, ACCORD), knowledge of local study management requirements
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, facilitate translation of documents, ensure SAE reconciliation, plan audit and inspection activities, provide input to process development
Seniority
Senior, hands-on IC