Senior Clinical Trial Manager
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Overview
In this role you will oversee early-phase clinical trials at the local level, ensuring scientific and operational delivery in Italy. You will work closely with the Clinical Trial Lead, CRAs, and regulatory start-up teams to drive trial progress. The position emphasizes leadership of the trial team, risk mitigation, and alignment with GCP/ICH and local regulations to accelerate patient access to therapies. This is a hybrid role in Lombardy, offering exposure to oncology studies and cross-functional collaboration within a sponsor-led program.
Responsabilità
- Lead and deliver assigned clinical trials at local level within defined milestones and KPIs
- Provide operational and scientific oversight and direction to the trial team
- Manage planning, execution, and risk mitigation for trial processes
- Coordinate with CTL, CRAs, regulatory start-up and external stakeholders
- Ensure compliance with GCP-ICH, SOPs and trial protocol; oversee CRO activities
- Develop and manage country/site-level engagement plans, recruitment and risk mitigation
- Oversee vendor services and budget management for R/OPU
- Support regulatory submissions and timely archiving of TMF and documents
- Assist with investigator meetings and trial results communication
- Maintain high-quality data and safety reporting while ensuring regulatory readiness
Requisiti fondamentali
- Master's degree or higher in Life Sciences
- 5+ years in clinical trial management
- Mandatory experience in Italy
- Experience with Oncology studies
- Expert knowledge of GCP and ICH guidelines
- Strong budgeting, financial oversight and vendor management skills
- Leadership capability to deliver through others
- Excellent organizational, analytical and problem-solving abilities
- Fluent Italian (C1) and good English
- Willingness to travel ~2 visits per month
- Location: Lombardy (Italy)
- Prior involvement with regulatory authority and ethics committee processes
- leadership
- cross-functional collaboration
- clear communication
- GCP/ICH compliance
- trial budgeting and financial oversight
- vendor management and outsourcing
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