Clinical Project Manager: Medical Devices Trials

Meditrial; Roma; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Meditrial is seeking a Clinical Project Manager to oversee clinical projects and studies, collaborating with Clinical Affairs to meet regulatory and company objectives. The role is office-based and requires leadership across trial timelines, budgets, and quality controls.

You will manage trial operations for US and international studies, ensure GCP compliance, support submissions, and coordinate with the clinical team to deliver on time and within scope and budget.

Formación

• Minimum 5 years of clinical research experience in Project Management, Data Management or Clinical Monitoring.
• Experience in medical devices, especially cardiovascular interventional cardiology or ICU-based trials.
• Solid knowledge of GCP/CFR/ICH guidelines, ISO9001 and ISO14155 ISO 13485.
• English and Italian language proficiency; a third language is appreciated.

Responsabilidades

• Proactively manage trial timelines, budget, resources with quality standards and risk mitigation.
• Provide project leadership and support for US and International Clinical Trials in compliance with laws, regulations and policies.
• Ensure conformance with GCP, trial protocols and adverse event reporting requirements.
• Lead projects that support division and company objectives and adhere to study execution strategy.
• Coordinate startup activities including TMF setup, site selection, CTAs and budgets; ensure priorities align with SOPs and regulatory requirements.
• Attend trial progress meetings, document minutes, and ensure timely TMF filing and issue resolution.
• Monitor deliverable quality and identify opportunities to improve training and QC across the clinical team.

Conocimientos

Project management

Clinical trials

GCP knowledge

Communication

Educación

Bachelor’s degree in Lifescience

Master in health-related field (a plus)

Descripción del empleo

Meditrial is seeking a Clinical Project Manager to oversee clinical projects and studies, collaborating with Clinical Affairs to meet regulatory and company objectives. The role is office-based and requires leadership across trial timelines, budgets, and quality controls.

You will manage trial operations for US and international studies, ensure GCP compliance, support submissions, and coordinate with the clinical team to deliver on time and within scope and budget.