An innovative Italian medtech startup, spin-off of a leading biomedical research institution, is developing a minimally invasive device for the treatment of Stress Urinary Incontinence. The device has been tested in two completed pilot studies and is currently being evaluated in an ongoing Italian clinical study across three centers, with an active FDA regulatory pathway underway.
The company is looking for a:
Medical Monitor — Urology
The Medical Monitor will serve as an independent clinical oversight figure during the ongoing pilot study, ensuring the highest standards of clinical and procedural quality across the study sites. This is a freelance, on-call engagement, with potential for continued involvement in future international clinical activities.
Main Responsibilities
- Attend on-site sessions at 3 Italian study centers during implant procedures
- Verify patient inclusion criteria
- Monitor the correctness of the implant procedure
- Review clinical documentation, including patient records and diagnostic imaging (e.g. ultrasound)
- Assess the quality of instrumental examinations performed at the sites
- Interface with Principal Investigators, nurses, study coordinators, and the CRO team
- Contribute to clinical reports for Notified Bodies and/or the Ministry of Health
Requirements
Must have:
- Experience in clinical trials or pilot studies on medical devices (pharma background alone is not sufficient)
- Knowledge of GCP (Good Clinical Practice) guidelines
- Clinical background — any specialty considered
- Hands-on, pragmatic approach — ability and willingness to work directly on-site
- Availability for travel to study centers in Italy
- Freelance status, or willingness to operate as such
Nice to have:
- Background in urology or uro-gynecology (strong plus)
- Experience as Medical Monitor or Senior CRA in medtech
- Familiarity with FDA regulatory pathway for medical devices
- Experience in the preparation of clinical reports for Notified Bodies and/or the Ministry of Health
- Fluent English
- Existing relationships with Italian urology centers
Engagement type: Freelance, on-call
Location: Anywhere in Italy — travel required
Location
Ovunque in Italia, con disponibilità a trasferte
Retribuzione: €800,00 - €1.100,00 al giorno
Sede di lavoro: Trasferte frequenti
