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 eTMF
Demonstrated digital mindset and willingness to actively leverage AI tools and emerging technologies to improve monitoring efficiency, data quality, and operational excellence
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📌 Clinical Research Associate 2 (Roma)
🏢 Altro
📍 Roma