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 communication

Collaborate cross-functionally to support milestone achievement and resolution of study issues

Planning & Performance Management

Develop 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

Required Skills and Qualifications

Bachelor’s degree in Life Sciences or related field

Minimum 3+ years as Project Manager and 5+ years of clinical research experience

Very good knowledge of clinical trial conduct, ICH-GCP, and regulatory requirements

Experience in set-up and conduct of Early Phase – Phase I and Phase II Clinical Trials

Therapeutic area knowledge in Oncology would be 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 in 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 Sponsor's office in Rome for at least 3 days per week

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

The potential base pay range for this role, when annualized, is 53 200,00 € - 79 800,00 €. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or tempo parziale). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

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📌 Clinical Operations Project Manager (Roma)
🏢 Altro
📍 Roma