Medical Monitor
Descrizione dell'offerta
Medical Monitor (MD)
Location: Milan, Italy
Work Model: Full-time, On-site (5 days per week)
Position Summary
We are seeking a highly qualified Medical Monitor (MD) to join our clinical development team based in Milan. This is a full-time, on-site role requiring daily presence in the office. The Medical Monitor will provide medical oversight for clinical trials, ensuring subject safety, protocol compliance, and scientific integrity throughout the study lifecycle.
The successful candidate will serve as the primary medical expert for assigned studies and collaborate closely with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and external investigators.
Key Responsibilities
- Provide medical oversight for ongoing clinical trials, ensuring patient safety and data integrity.
- Serve as the primary medical contact for investigators and study sites.
- Review and assess eligibility criteria, protocol deviations, and medical data.
- Evaluate and adjudicate adverse events (AEs/SAEs) and support safety signal detection.
- Contribute to protocol development, amendments, and clinical study reports.
- Participate in investigator meetings and site training as needed.
- Collaborate with Pharmacovigilance on safety reporting and risk management.
- Support regulatory submissions and responses to health authority queries.
- Review and approve medical narratives and safety summaries.
- Provide medical input into informed consent forms and patient-facing materials.
- Ensure compliance with ICH-GCP, EU regulations, and company SOPs.
Qualifications & Requirements
- Medical Degree (MD) required.
- Valid medical license (EU-recognized).
- Minimum 3–5 years of experience in clinical research (pharmaceutical, biotech, or CRO environment).
- Prior experience as a Medical Monitor or in a comparable clinical development role preferred.
- Strong knowledge of ICH-GCP, EMA regulations, and EU clinical trial requirements.
- Experience in safety evaluation and adverse event assessment.
- Excellent scientific judgment and analytical skills.
- Strong communication skills in English (Italian fluency preferred).
- Ability to work on-site in Milan 5 days per week.
Preferred Qualifications
- Experience in (insert therapeutic area, e.G., oncology, rare diseases, immunology).
- Experience interacting with regulatory authorities.
- Experience in global, multi-center trials.
- Board certification in a relevant specialty (advantageous).
Key Competencies
- Clinical expertise and sound medical judgment
- Attention to detail and patient-safety focus
- Cross-functional collaboration
- Decision-making under time-sensitive conditions
- High ethical standards and professionalism
What We Offer
- Opportunity to contribute to innovative clinical development programs
- Collaborative and science-driven environment
- Competitive compensation package
- Career growth within a dynamic organization