Clinical Trial Manager

05 ago - Italia
Scienza / Ricerca / Sviluppo

KEY RESPONSIBILITIES Si candidi (facendo clic sul pulsante apposito) dopo aver controllato tutte le informazioni di lavoro riportate di seguito. Accountable for the operational and scientific oversight, set‐up, execution and delivery of assigned clinical trials at regional and local levels. Provides leadership and direction to the Operational Unit trial team, and is accountable for overall success and delivery of their assigned clinical trial(s) according to defined milestones and key performance indicators. Responsible for steering and directing clinical trial activities, including patient and site engagement and interaction with multiple internal and external stakeholders and trial team members at regional, local, and global levels. Responsible for managing the planning, implementation and tracking of the clinical trial process as well as risk mitigation; serves as a proactive member of the trial team, liaising closely with the Clinical Trial Leader (CTL) on all study‐related issues. Trial Preparation, Conduct and Closeout: Accountable for the trial activities for responsible R/OPU.



Verify the trial is conducted in compliance with GCP‐ICH, local/global regulations, application SOPs and trial protocol by overseeing CRO and internal team activities. Creation, management, and review of the R/OPU trial budget to verify appropriate level of financial oversight and planning accuracy. Appropriate trial‐specific training of R/OPU internal and external partners. Accurate planning and coordination of operational feasibility of trial timelines for R/OPU; oversight of trial preparation to verify trial team members are aligned and on track. Verifies and provides input into the country and site level feasibility and OPU commitment. Development and implementation of country‐level engagement plans, recruitment planning and risk mitigation. Oversees outsourcing of vendor services in R/OPU in accordance with operating models and governance. Verify timely responses to questions from

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