LocalStudyAssociateDirector

To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), the Local Study Associate Director (LSAD) may perform site monitoring as needed to support the flexible capacity model. The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. LSADs s might have different internal titles based on the experience level (LSAD, Senior LSAD). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head Senior Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head / Executive Director, Regional Head. Typical Accountabilities • 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 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. • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for