25 set - Italia
Jobtailor
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 e TMF 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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