Clinical Operations Project Managers are an integral part of clinical trial delivery, working closely with clinical teams and sponsors to improve patients' lives by bringing new drugs to market faster. Within a sponsor-dedicated Functional Service Provider (FSP) model, the Clinical Operations Project Manager (COPM) is an essential member of the core project team, responsible for the operational delivery of clinical studies at regional level. The COPM ensures studies are conducted in accordance with contractual requirements, timelines, quality standards, and applicable regulations. This role combines hands-on clinical operations oversight with strong project coordination and stakeholder management, with a particular focus on site-facing activities, CRA functional leadership, and execution excellence.
Responsibilities
Study Oversight & Delivery
Accountable for the execution of clinical trials in Italy and Greece, ensuring delivery according to timelines, budget, and quality expectations
Monitor study progress against milestones and proactively manage risks, issues, and contingencies

Ensure compliance with ICH-GCP, SOPs, and applicable regulatory requirements
CRA Functional Management & Site Engagement
Provide functional oversight and guidance to assigned CRAs, ensuring high-quality monitoring and performance
Supervise CRA training at study level (protocol, monitoring plan, study tools, etc.)
Accompany CRAs on key visits (e.g., SIVs, audits) as needed to support study conduct and site engagement
Quality & Compliance
Review and approve monitoring visit reports and follow-up communications
Ensure protocol adherence and oversee protocol deviations, root cause analyses, and CAPA implementation
Support inspection readiness and oversee audit findings resolution
Perform or support Study Evaluation Visits (SEVs) when required
Project Coordination & Stakeholder Management
Act as a key interface between sponsor and operational teams, ensuring alignment and transparent communicat

Clinical Operations Project Manager

System engineer

URGENTE DOCENTE OPERATORE CAF MILANO

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