Project Manager Clinical Research Italy Milan

We are looking for a Project Manager (Clinical Research) with experience to join our team in Milan .

Since 1997, AMS Advanced Medical Services has been operating successfully across Europe as a Contract Research Organization (CRO) in the field of clinical research. Our established clients include major pharmaceutical companies and medical device manufacturers. Our company is characterized by team spirit, integrity, and a strong commitment to collaboration.

Responsibilities

• Organize and coordinate national and international clinical trials in compliance with current regulations and sponsor requirements.
• Prepare and draft trial-related documentation (e.g., study protocols, informed consent forms, site contracts).
• Coordinate and supervise CRAs.
• Prepare and submit application dossiers to AIFA and/or via the CTIS portal.
• Supervise and monitor project budgets.
• Manage cross‑functional working groups.
• Provide regulatory advice to AMS staff and/or sponsors on Italian legal requirements.
• Be responsible for the start‑up and serve as the primary contact person for the AMS office in Milan.
• Contribute to our interdepartmental EU HTA network.

Qualifications

• Degree in life sciences.
• At least 3 years of experience in clinical study start‑up activities in Italy, including practical experience in submitting applications to AIFA, for both observational and interventional studies regarding medicinal products and medical devices.
• Proven experience in project management in clinical research.
• Authorization to conduct monitoring visits independently as a CRA in Italy (as required by the Ministerial Decree of November 15, 2011).
• Excellent communication skills (both written and verbal).
• Structured, reliable, and result‑oriented approach to work.
• High sense of responsibility, ability to work independently, and flexibility in terms of hours and tasks.
• Fluency in Italian and English.

Benefits

• A professional, close‑knit, open‑minded, and friendly team that enjoys collaborating.
• Flat hierarchies.
• Flexible working hours.
• Periodic trips to the headquarters in Mannheim for in‑person meetings with the team.
• Excellent opportunities for professional growth within an expanding company.