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 e TMF Demonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence

📌 Clinical research associate 2 (Roma)
🏢 Jobtailor
📍 Roma