Clinical Project Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7xzlo8

Clinical Project Manager

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

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Requirements : At least 4 years of experience as a Project Manager

Work Location: Rome, Italy

Key Responsibilities

- 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

- 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

- 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

- 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. xjncmbx
- Workplace based in Rome, Italy.

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7xzlo8