Lead Complex Clinical Studies — Rome PM

Crolife

Lazio

In loco

EUR 85.000 - 105.000

Tempo pieno

6 giorni fa

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Descrizione del lavoro

Crolife is seeking a Clinical Project Manager to join its Clinical Operations team in Rome, Italy. You will lead interventional and non-interventional studies, coordinating cross-functional teams to ensure on-time, on-budget delivery in line with GCP and SOPs.

The role requires 4+ years in clinical project management, strong leadership and communication skills, and proficiency in English. You will oversee documentation, regulatory submissions, TMF, and vendor contracts, with opportunities for

Competenze

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.

Mansioni

Lead, coordinate, and oversee interventional and non-interventional clinical studies involving medicinal products, medical devices, and medical nutrition.
Manage cross-functional project teams, including CPS, CTA, CRA, Data Managers, Medical Advisors, Biostatisticians, and external vendors.
Ensure that clinical projects are delivered on time, within budget, and in compliance with GCP, applicable regulations, and 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 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.