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
Collaborate with site staff and cross-functional teams
Build trusted partnerships with investigators and site staff
Conducting on-site and remote visits
Driving the implementation of Risk-Based Quality Management (RBQM) principles
Overseeing site performance, recruitment progress, retention and data collection
Leading site training and providing continuous support on study protocols

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
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
Excellent stakeholder management, communication and negotiation skills
Strong organisational and time management skills
Fluency in both Italian and English (written and spoken)

Clinical Research Associate II

Key skills