Clinical Project Manager

3 giorni fa

Piedimonte, Lazio, Italia CROlife Tempo pieno

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Clinical Project Manager

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

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.

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