Clinical Project Manager (Permanent)

Crolife; Lazio; In loco; EUR 85.000 - 105.000; Tempo pieno

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.

Conoscenze

Leadership

Organizational skills

Communication skills

Negotiation skills

Project Management

Budget management

English proficiency

Formazione

Bachelor's or Master's in Life Sciences or related

Descrizione del lavoro

Clinical Project Manager

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

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. xysqume
• Workplace based in Rome, Italy.