LSAD (Local Study Associate Director)
Core
Manage assigned clinical studies and lead Local Study Teams to ensure country-level delivery of study commitments according to budget, timeline, and resources.
Role type
Senior IC clinical study director (country-level)
Builds
Country-level clinical studies for AstraZeneca
Domain
Pharmaceutical clinical trials
Required skills
Clinical study management, Local Study Team leadership, Site selection and qualification, Regulatory submission coordination, Budget and financial management, Monitoring oversight, Risk management, Investigator relations, Audit and inspection readiness, Process improvement
Preferred skills
Site monitoring experience, National Investigator meeting leadership, Patient recruitment strategy
Technologies
CTMS, eTMF, Clinical financial systems
Responsibilities
Lead Local Study Teams (CRAs, CSAs) for assigned studies; Coordinate site selection, qualification, and monitoring activities; Ensure timely submission to Ethics Committees and Regulatory Authorities; Manage country-level study budgets and financial agreements; Oversee monitoring activities and review reports; Plan and lead National Investigator Meetings; Maintain eTMF in Inspection Ready state; Coordinate audit and regulatory inspection activities; Contribute to patient recruitment strategies.
Seniority
Senior, hands-on IC