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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📌 Clinical Research Associate 2 (Roma)
🏢 Jobtailor
📍 Roma