21 ott - Lazio
Iqvia
OverviewClinical Operations Project Managers are an integral part of clinical trial delivery, working closely with clinical teams and sponsors to bring new drugs to market faster.
Within a sponsor-dedicated Functional Service Provider (FSP) model, the Clinical Operations Project Manager (COPM) is a core team member responsible for the operational delivery of studies at the 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, stakeholder management, site-facing activities, CRA functional leadership, and execution excellence.
ResponsibilitiesStudy Oversight & DeliveryAccountable 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 EngagementProvide functional oversight and guidance to assigned CRAs, ensuring high?quality monitoring and performance.
Supervise CRA training at the 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 & ComplianceReview 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 ManagementAct as a key interface between sponsor and operational teams, ensuring alignment and transparent communication.
Collaborate cross?functionally to support milestone achievement and resolution of study issues.
Planning & Performance ManagementDevelop and maintain study plans and timelines, ensuring on?time delivery.
Organize regular study follow?up meetings with CRAs and stakeholders.
Provide structured feedback on team performance and contribute to continuous improvement.
QualificationsBachelor's degree in Life Sciences or a related field.
Minimum 3+ years as a Project Manager and 5+ years of clinical research experience.
Very good knowledge of clinical trial conduct, ICH?GCP, and regulatory requirements.
Experience in the set?up and conduct of Early Phase – Phase I and Phase II Clinical Trials.
Therapeutic area knowledge in Oncology is an advantage.
Proven experience in site management, CRA oversight, and cross?functional coordination.
Strong communication and stakeholder management skills.
Ability to manage multiple priorities in a matrix environment.
Very good command of English language.
Strong operational leadership and coordination capabilities.
Excellent problem?solving and risk management skills.
Strong attention to quality, compliance, and detail.
High level of collaboration across teams, functions, and geographies.
Willingness to work at the sponsor's office in Rome for at least 3 days per week.
Compensation and BenefitsThe potential base pay range for this role is€53,**–€79,**annualized.
Incentive plans, bonuses, and health and welfare benefits may be offered based on qualifications, location, and schedule.
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