Local Study Associate Director

Job description About AstraZeneca AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world s most serious diseases. But we re more than one of the world s leading pharmaceutical companies. Job Description 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 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 (fSMA) 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 timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant AZ SOPs and local regulations. 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). Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. Reviews monitoring visit reports (as required and following AZ SOPs) and pro-actively advices the monitor(s) on study related matters. Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. Proactively identifies risks and facilitates resolution of complex study problems and issues. Organises regular Local Study Team meetings on an agenda driven basis. Actively works towards achieving good personal relation