Your new role As a Clinical Research Associate II, you will provide strategic oversight and management of clinical trial sites, ensuring protocol compliance, data integrity, and the protection of patient safety and rights. You will drive study quality and performance through risk-based monitoring and proactive risk management, collaborating with site staff and cross‐functional teams to ensure the successful execution of our trials. Your key responsibilities will include: Act as a Site Manager, building trusted partnerships with investigators and site staff, driving site engagement and performance, and ensuring high‐quality trial execution throughout the study lifecycle. Conducting on‐site and remote visits (site selection, initiation, monitoring and close‐out) in accordance with the Monitoring Plan, Protocol, ICH‐GCP, internal SOPs and regulatory requirements. Driving the implementation of Risk‐Based Quality Management (RBQM) principles to proactively identify, assess and mitigate risks throughout study conduct. Overseeing site performance, recruitment progress,

retention and data collection to ensure that timelines and quality objectives are met. Leading site training and providing continuous support on study protocols, systems and compliance requirements. Managing IMP, study supplies, essential documents and the Investigator Trial Master File to ensure accountability and compliance. Your new department In Global Trial Portfolio (GTP), you'll be part of a department that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an innovative pipeline to meet future patient needs. You will join the Clinical Development Centre (CDC), the dedicated hub for clinical operations in Italy and an integral part of Trial Operations EUCAN in the GTP department. Here, a team of passionate professionals brings N

Clinical research associate 2

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