Clinical Trial Manager - Italy (Milan) - Infectious Disease / Immunology

Experteer Overview

In this role you will lead Milan-based trial operations, ensuring compliance with ICH/GCP and regulatory requirements. You will serve as the primary Sponsor liaison for operational issues and study deliverables, while overseeing cross‑functional teams and training. You will review protocols and data plans, develop operational project plans, and manage risks and vendors. You may focus on Immunology and Infectious Diseases or expand to new therapeutic areas within a supportive, flexible environment.

Responsibilities

• Manage day‑to‑day operations of the project per contract and regulatory standards
• Serve as primary Sponsor contact for operational issues and study deliverables
• Maintain in‑depth knowledge of protocol, therapeutic area, and indication
• Provide cross‑functional oversight and ensure training for project team members
• Review and provide input for study protocol, edit check specs, data analysis plan, and final study report
• Develop operational project plans
• Manage risk assessment and execution
• Oversee study vendors
• Manage site quality and supervise Clinical Research Associates and monitoring deliverables

Qualifications

• Bachelor's degree in a health or life science‑related field
• Advanced degree in a health or life science‑related field preferred
• Experience in Phases 1-4; Phases 2-3 preferred
• Minimum of 2 years of Clinical Trial Management experience; CRO experience preferred
• Management of overall project timeline
• Bid defense experience preferred
• Strong leadership skills

Benefits

• Flexible work environment
• Competitive compensation and benefits package
• Competitive PTO packages
• Structured career paths with opportunities for professional growth
• Company‑sponsored employee appreciation events
• Employee health and wellness initiatives