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Información sobre: Dpto Médico/ Site Management & Monitoring en Madrid

Empresa buscando Dpto Médico/ Site Management & Monitoring

Estado sin definir, España
Sobre la oferta de: Dpto Médico/ Site Management & Monitoring
Descripción de la oferta

Major responsibilities: •         Assist in coordination and administration of clinical studies from the start-up to execution and close-out. •         Collect, assist in preparation, review and tracking of documents for the application process (HA/IEC). Interface with Investigators, external service provider and CRAs during the collection process to support effective delivery of a study and its documents. Serve as local administrative main contact and work closely with CRAs and/or the LSTL until finalization of the study. •         Support the Set-up of Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements. Support the CRA in the maintenance and close out activities for the ISF. •         Contribute to the production and maintenance of study documents, ensuring template and version compliance. •         Know to how to Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint, Archivex, etc) •         Support the practical arrangements and contribute to the preparation of internal and external meetings e.g. study team meetings, monitor meetings, Investigator meetings. Liaise with internal and external participants and/or vendors •         Support additional country-specific tasks depending on country need.  Condiciones: Contrato: Beca de 1 año (6 meses + 6 meses) Remuneración: 750€/mes Jornada completa: De 9.00h a 18.00h Posiciones: 1

Descripción del candidato

Skills and Competences: •          Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines •         Computer skills •         Good English knowledge •         Good interpersonal skills and ability to work with other team members •         Integrity and high ethical standards 

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