Regional Clinical Trial Management Associate - Spain & Portugal |

Detalles de la oferta

.Detalles del empleoAsí es cómo la información del empleo se alinea con tu perfil.Tipo de empleo:- Jornada completaUbicación:- En remotoDescripción completa del empleo:BeiGene 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 budget.Essential Functions of the job:Regional Trial Support & Collaboration:Develops 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 guidelines.Supports the Regional Clinical Study Manager with set up and logistics of regional team meetings (agenda, minutes, etc.).Establishes good collaboration with Regional Clinical Study Manager, the Global Study Management Associate and other key stakeholders regionally and globally.As required, supports CRAs with various activities such as monitoring visit preparations, TMF filing, etc.Timelines, Planning and Execution:Creates and maintains regional/country level SharePoint folders for the study and regional study team distribution lists.Sets up the countries and sites in the region in the appropriate systems (e.G. eTMF, CTMS, etc.) and makes sure information is kept up to date.Supports system access requests for the region/country and ensures these are managed appropriately across the study life cycle, supports user account management for users in region.Might support the local adaptation of global documents under supervision of the Regional Clinical Study Manager.May assist in the review of study-related documents as they relate to the supported clinical trials as delegated by the Regional Clinical Study Manager.Quality:Supports the identification of operational risks and works with the Regional Clinical Study Manager to recommend solutions for discussion with appropriate team leadership.Learns and shares best practices in clinical operations methodologies, systems and processes with the emphasis on quality and compliance.Might support the preparation of sites for quality assurance audits and inspections.Education Required:- Bachelor's Degree in a scientific or healthcare discipline required, Higher Degree preferred.- Exceptions might be made for candidates with relevant clinical operations experience


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