Local Study Associate Director
Core
Lead the execution of global clinical studies within a specific country, directing local study teams to deliver study components on time and within budget while adhering to AZ procedures, ICH-GCP guidelines, and local regulations.
Role type
Senior local study associate director (clinical trials)
Builds
Clinical study delivery for pharmaceutical trials
Domain
Healthcare / Clinical Research
Deliverable
client delivery
Required skills
Clinical research project management, site selection and qualification, ethical and regulatory submission management, clinical trial budgeting, contract negotiation, CTMS administration, eTMF management, site monitoring oversight
Preferred skills
On-site monitoring experience, CRA training and mentoring
Technologies
CTMS, eTMF
Responsibilities
Lead local study teams (CRAs/CSAs) for assigned studies; coordinate site selection, identification, and qualification; manage ethical and regulatory submission documentation; prepare clinical study budgets and researcher contracts; oversee essential document collection, drug importation, and provider account setup; maintain country-level CTMS and coordinate monitoring activities; conduct co-monitoring or CRA training visits; ensure eTMF completeness and currency; report on study milestones and team performance to country line directors.
Seniority
Senior, hands-on IC
