Experteer Overview In this role you ensure robust clinical trial compliance at the country and site level, using a risk‐based approach to safeguard patient safety and data integrity. You work with country, regional and global stakeholders to meet GCP and regulatory standards, and to maintain inspection readiness. You will lead risk identification, site oversight, and CAPA processes, enabling compliant and high-quality study conduct. This is a mission‐driven role for a collaborator who drives continuous improvement in oncology trials. Retribuzione / Benefits Act as the primary contact for country teams on GCP, procedures, and compliance queries Perform risk‐based country and site oversight, identify high‐risk sites, and communicate trends for continuous improvement Coordinate with Global Clinical Compliance to execute the Study Health Check Plan at country/site level Lead process reviews and site visits for high‐risk sites in collaboration with Clinical Operations Support identification,



management and resolution of compliance issues and CAPAs with risk assessment and root cause analysis Assist Regional Clinical Compliance Inspection and Audit Support team in site audits and inspections preparation Responsabilità Thorough understanding of ICH‐GCP and regulatory guidelines Strong analytical and problem‐solving abilities High attention to detail and quality orientation Excellent English and Italian written and verbal communication and stakeholder management skills Ability to work independently in a multicultural, fast‐paced environment Experience in clinical operations and GCP compliance (5+ years in operations, 4+ years in compliance preferred) Experience in oncology global trials preferred Bachelor in scientific, medical or healthcare discipline (or equivalent) #J-18808-Ljbffr

📌 Regional clinical compliance manager (Italia)
🏢 Experteer Italy
📍 Italia