BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General Description:Supports the Regional Clinical Study Manager in regional study delivery and ensures that delegated components of clinical studies are executed per expected and specified quality standards, within timelines and budgetBuilds solid knowledge of clinical trials operations in the region under guidance of the Regional Clinical Study ManagerSupports the alignment of regional deliverables with overall study goals under the direction of the Regional Clinical Study ManagerEssential Functions of the job: Regional Trial Support & CollaborationDevelops regional study management experience by supporting to oversee multiple aspects of clinical trial conduct including feasibility assessment, study start-up, document generation and review,
tracking of samples and enrollment of study participants.Acquires solid knowledge of clinical research operations, including interpretation and implementation of regulations/ICH guidelinesSupports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, ..)Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globallyAs required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, ..Timelines, Planning and ExecutionCreates and maintains regional/country level SharePoint folders for the study and regional study team distribution listsSets up the countries and sites in the region in the appropriate systems e.g. eTMF, CTMS, ..and makes sure information is kept up to dateSupports system access requests for the region/country and ensure these are managed
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