Global Clinical Project Lead – Complex Studies & Growth

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

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.