10 set - Roma
CROlife
Clinical Project Manager
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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
10 set - Milano
During S.p.A. Filiale di Milano Cadorna
10 set - Turbigo
Altro
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