.Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.THIS IS A REMOTE POSITIONSummary of the groupTo 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.Main Duties & ResponsibilitiesHas 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/studiesLeads and optimizes 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 submissions to Regulatory Authority for the duration of the study, and in line with local regulations.Ensures timely preparation of country financial Study Management Agreement and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction)
