02 set - Roma
Jobtailor
Responsibilities
Scorra verso il basso per trovare i dettagli completi dell'offerta, inclusa l'esperienza richiesta e le mansioni associate.
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- 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
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- 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 xysqume 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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