Clinical Research Associate Ii

06 ago - Italia
Altro

Are you passionate about clinical research and driven by the opportunity to bring life-changing therapies closer to patients? Join Novo Nordisk in Italy as a Clinical Research Associate II and play a pivotal role in shaping the future of clinical trials in obesity, diabetes and other serious chronic diseases. Apply today for a career where your expertise makes a tangible difference.
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
The ideal candidate is physically based in one of the following cities: Rome, Milan, Florence, Bologna, or Naples.
Your new department
In Global Trial Portfolio (GTP), you'll be part of a department that explore

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