Experteer Overview As Local Study Associate Director, you drive the country-level execution of committed study components within time, budget, and quality targets. You lead Local Study Teams to ensure adherence to ICH-GCP and local regulations while coordinating site identification, setup, monitoring, and documentation. You may perform site monitoring to support a flexible capacity model. This role blends leadership, regulatory focus, and site-level operations to deliver reliable data and compliant trials. Retribuzione / Benefits Own study commitments for the country and ensure timely data delivery at required quality Lead Local Study Team(s) comprising CRA(s) and CSA(s) to achieve study goals Coordinate site selection, Site Quality Risk Assessments,



and Site Qualification Visits Oversee regulatory submissions to EC/IRB and Regulatory Authority in line with local regulations Manage country-level financials and country Master CSA/MICF documentation and amendments Set up and maintain CTMS and local websites per local laws Oversee monitoring activities from activation to closure and guide monitors on study matters Identify risks and coordinate resolution of complex study issues Foster cross-functional collaboration and build relationships with sites, investigators, and stakeholders Ensure readiness of trial documents for e TMF archiving and lead local audits/regulatory inspections Contribute to risk management planning and patient recruitment strategy Communicate progress to Global Study leadership and Line Managers Ensure compliance with Sponsor Ethics, company policies, and SHE policies Collaborate with Medical Affairs and support SMM initiatives Provide input to process improvements and local policy adherence Location-based requirement per sponsor Responsabilità Bachelor degree in related discipline, preferably life science Minimum 3 years of Development Operations or related fields (CRA/Sr CRA) Good knowledge of ICH-GCP and local regulations Proven leadership of cr

📌 Local study associate director (Italia)
🏢 Experteer Italy
📍 Italia