Clinical Project Manager

5 giorni fa

Milano, Italia Amygdal A tempo pieno

Our client, an innovative and growing company in the cardiovascular medical device sector, is seeking a:
**Clinical Project Manager**

a key figure responsible for leading and coordinating all activities related to clinical investigations for cardiovascular products. This role plays a central part in ensuring regulatory compliance, managing timelines, and overseeing clinical vendors and internal resources.

**Key Responsibilities**
- Draft, review, and manage clinical investigation documentation (e.g., CIP, CRF, ICF, monitoring plans)
- Lead the preparation of interim and final Clinical Investigation Reports
- Oversee planning and execution of clinical trial activities: site selection, start-up, enrollment tracking, monitoring, and close-out
- Ensure regulatory compliance with FDA 21 CFR Part 812, ISO 14155, and EU MDR
- Select and manage vendors (EDC providers, Core Labs, CROs), including contracting and performance oversight
- Collaborate with cross-functional teams: R&D, Regulatory, Quality, Medical Affairs, Data Management, and Biostatistics
- Support regulatory documentation and submissions (e.g., CE Mark, De Novo)
- Identify and mitigate project risks; maintain audit/inspection readiness
- Build strong relationships with investigators and Key Opinion Leaders (KOLs)
- Train and mentor junior clinical staff

**Required Competencies**
- Master’s degree in Life Sciences, Biomedical Engineering, Nursing, or related field (advanced degree preferred)
- 7-10 years of experience in clinical research, including at least 3 years managing pre-market clinical trials
- Knowledge of cardiovascular medical devices is a strong plus
- Deep understanding of MDR, FDA, and international clinical regulatory frameworks
- Excellent leadership and communication skills
- Full professional proficiency in English

**Location**:Milan

Contratto di lavoro: Tempo pieno, Tempo indeterminato

Retribuzione: €70.000,00 - €85.000,00 all'anno

Disponibilità:

- Dal lunedì al venerdì

Esperienza:

- clinical research: 7 anni (Obbligatorio)

Lingua:

- inglese (Obbligatorio)

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