ph3Responsibilities /h3 ul liProvide strategic oversight and management of clinical trial sites /li liEnsure protocol compliance, data integrity, and the protection of patient safety and rights /li liDrive study quality and performance through risk-based monitoring and proactive risk management /li liCollaborate with site staff and cross-functional teams to ensure the successful execution of trials /li liAct as a Site Manager and build trusted partnerships with investigators and site staff /li liConduct on-site and remote visits in accordance with the Monitoring Plan, Protocol, ICH-GCP, internal SOPs and regulatory requirements /li liDrive the implementation of Risk-Based Quality Management (RBQM) principles /li liOversee site performance, recruitment progress, retention and data collection /li liManage IMP, study supplies,



essential documents and the Investigator Trial Master File /li /ul h3Requirements /h3 ul liA bachelor's degree in Life Sciences (preferably Biotechnology, Pharmacy, Chemistry, Biology or CTF) /li liA minimum of 3 years of clinical trial monitoring experience within the pharmaceutical industry or a CRO /li liProven independence in monitoring activities and strong expertise in applying ICH-GCP E6(R3), clinical trial methodology, regulatory requirements, and SOPs /li liValid GCP certification required /li liSolid working knowledge of electronic clinical trial systems, including CTMS, EDC, IWRS and eTMF /li liDemonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence /li /ul /p #J-18808-Ljbffr

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