Clinical Project Manager

CROlife; Roma; In loco; EUR 70.000 - 110.000; Tempo pieno

Descrizione del lavoro

CROlife is seeking a Clinical Project Manager to lead and oversee clinical studies within our Clinical Operations team. The role requires coordinating multidisciplinary teams and ensuring projects meet GCP standards, timelines, and budgets.

The CPM will prepare study documentation, manage regulatory submissions, and maintain TMF integrity across the study lifecycle. Strong leadership and English communication are essential for success in this role.

Competenze

• 4+ years of experience as a Project Manager in clinical research.
• 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, regulations, and SOPs.
• Prepare and oversee study documentation, including protocols, IBs, 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 updates to sponsors and internal stakeholders.
• Oversee TMF management and ensure documentation throughout the study lifecycle.
• Manage project budgets, contracts with clinical sites and external vendors, and financial performance.
• Support QA activities, including CAPA, KPI monitoring, and audit readiness.
• Act as the primary point of contact for sponsors and project teams.

Conoscenze

Project Management

Leadership

Communication

Negotiation

Budget management

Cross-functional teams

English proficiency

Formazione

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

Descrizione del lavoro

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

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.