Senior Clinical Trial Manager Oncology

10 ore fa
Milano, Provincia di Milano; Lombardia, Italia IQVIA Tempo pieno
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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