LSAD (Local Study Associate Director)
Core
Manage assigned clinical studies and lead Local Study Teams to ensure country-level study commitments are delivered on time and within budget.
Role type
Senior Clinical Operations Manager (Country Level)
Builds
Country-level clinical studies for AstraZeneca
Domain
Pharmaceutical / Clinical Operations
Required skills
Clinical Operations leadership, Site selection and qualification, Budget and financial management, Regulatory submission coordination, Risk management, Team management, Monitoring oversight, Stakeholder management
Preferred skills
Experience in Medical Affairs-led or academic-led studies
Technologies
CTMS, eTMF, Clinical financial systems
Responsibilities
Lead Local Study Teams (CRAs, CSAs) for assigned studies; Coordinate site selection, qualification, and monitoring activities; Prepare country-level financial agreements and manage study budgets; Submit applications to Ethics Committees/IRBs and Regulatory Authorities; Oversee monitoring activities and review reports; Plan National Investigator Meetings; Manage study eTMF for inspection readiness; Conduct audit and regulatory inspection activities.
Seniority
Senior, hands-on IC