Clinical Project Manager
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We are looking for a Clinical Project Manager (CPM) to join our Clinical Operations team.

Work Location: Rome, Italy

Key Responsibilities

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- Lead, coordinate, and oversee interventional and non-interventional clinical studies involving medicinal products, medical devices, and medical nutrition.

- Manage cross-functional project teams, including Clinical Project Specialists (CPS), Clinical Trial Assistants (CTA), Clinical Research Associates (CRA), Data Managers, Medical Advisors, Biostatisticians, and external vendors.

- Ensure that clinical projects are delivered on time, within budget, and in compliance with Good Clinical Practice (GCP), applicable regulations, and company Standard Operating Procedures (SOPs).

- Prepare and oversee study documentation, including protocols, Investigator's Brochures (IB), IMPDs, and regulatory submission packages.

- Coordinate regulatory submissions and communications with Ethics Committees and Competent Authorities.

- Monitor project progress, identify and manage risks, and provide regular updates to sponsors and internal stakeholders.

- Oversee Trial Master File (TMF) management and ensure appropriate documentation throughout the study lifecycle.

- Manage project budgets, contracts with clinical sites and external vendors, and financial performance.

- Support quality assurance activities, including CAPA implementation,



KPI monitoring, and audit readiness.

- Act as the primary point of contact for sponsors and project teams throughout the duration of assigned studies.

Requirements

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- Bachelor's or Master's degree in Life Sciences or a related scientific discipline.

- At least 4 years of experience as a Project Manager in the clinical research field.

- Knowledge of Good Clinical Practice (GCP) and Project Management methodologies.

- Experience managing project budgets and cross-functional teams.

- Strong leadership, organizational, communication, and negotiation skills.

- Ability to manage multiple priorities while maintaining a strategic overview.

- Good written and verbal communication skills in English.

Preferred Qualifications

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- Previous experience managing interventional and/or non-interventional clinical studies.

- Experience with regulatory submissions to Ethics Committees and Competent Authorities.

- Knowledge of Trial Master File (TMF) management and applicable clinical research regulations.

- Experience working in a Contract Research Organization (CRO) or pharmaceutical environment.

What We Offer

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- Dynamic and international work environment.

- Opportunity to lead complex and innovative clinical research projects.

- Professional growth and career development.

- Training and continuous learning opportunities.

- Collaborative and multidisciplinary team. xysqume xysqume

- Workplace based in Rome, Italy.

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📌 Clinical Project Manager (Permanent) (Gallicano Nel Lazio)
🏢 CROlife
📍 Gallicano Nel Lazio