Local Study Associate Director

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of Study Start-up Manager(s), Contract Manager(s), CRA(s), CSA(s), for assigned study/studies
• Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with AZ Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• Leads the site selection process by identifying potential sites/investigators with Feasibility Lead (and (acting) Site Engagement Lead- where applicable) , performing initial Site Quality Risk Assessment in collaboration with CRA, and conducting or overseeing Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the ...