Clinical Trial Manager
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In this role you will manage Early Phase clinical trials in Italy, ensuring operational and scientific oversight from setup to delivery. You will work closely with the Clinical Trial Lead, CRAs and regulatory start-up team to drive timely, compliant trial execution. You’ll oversee budgeting, risk mitigation and cross-functional coordination to advance sponsor pipelines and patient access. This position offers hybrid work in Lombardy and collaboration with key clients to shape trial outcomes.
Responsabilità- Oversee local-level operational and scientific trial delivery aligned with milestones and KPIs
- Provide leadership to the trial team and manage cross-stakeholder engagement locally and globally
- Plan, implement and track trial processes with risk mitigation and liaison with CTL
- Ensure compliance with GCP-ICH, local/global regulations, SOPs, and protocol
- Create, manage and review R/OPU trial budget and provide financial oversight
- Coordinate trial timelines, training for R/OPU partners, and feasibility assessments
- Oversee outsourcing of vendor services and governance
- Ensure timely regulatory submissions and responses; maintain TMF archiving
- Support investigator meetings and share trial results with sites/patients
- Maintain high-quality monitoring, safety reporting and alignment with regulatory requirements
- Master's in Life Sciences (preferred)
- 2 to 4 years of clinical trial management experience
- Mandatory prior involvement in trials conducted in Italy
- Oncology experience is advantageous
- Expert knowledge of GCP and ICH guidelines
- Strong project, financial and vendor management skills
- Fluency in Italian (C1) and good English
- Excellent organizational, analytical and communication skills
- Ability to travel domestically (~2 visits/month)
- leadership
- collaboration
- problem-solving
- GCP/ICH compliance
- trial budgeting and financial oversight
- vendor management
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