To lead Local Study Teams (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Sponsor 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 may perform site monitoring as needed to support the flexible capacity model. The Local Study Associate Director is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived. Responsibilities 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. Optimises the performance of the Local Study Team at country level ensuring compliance with Sponsor 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. Prepares country financial Study Management Agreement (f SMA) and maintains accurate study budget in Sponsor clinical studies financial system. Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. Prepares country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any

📌 Local study associate director (Italia)
🏢 Iqvia
📍 Italia