Responsibilities * Provide strategic oversight and management of clinical trial sites * Ensure protocol compliance, data integrity, and the protection of patient safety and rights * Drive study quality and performance through risk-based monitoring and proactive risk management * Collaborate with site staff and cross-functional teams to ensure the successful execution of trials * Act as a Site Manager and build trusted partnerships with investigators and site staff * Conduct on-site and remote visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements * Drive the implementation of Risk-Based Quality Management (RBQM) principles * Oversee site performance, recruitment progress, retention and data collection * Manage IMP, study supplies,



essential documents and the Investigator Trial Master File Requirements * A bachelor's degree in Life Sciences (preferably Biotechnology, Pharmacy, Chemistry, Biology or CTF) * A minimum of 3 years of clinical trial monitoring experience within the pharmaceutical industry or a CRO * Proven independence in monitoring activities and strong expertise in applying ICH-GCP E6(R3), clinical trial methodology, regulatory requirements, and SOPs * Valid GCP certification required * Solid working knowledge of electronic clinical trial systems, including CTMS, EDC, IWRS and eTMF * Demonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence #J-*****-Ljbffr

📌 Clinical Research Associate 2 (Lazio)
🏢 Jobtailor
📍 Lazio