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:
in coordination and administration of clinical studies from the start-up to
execution and close-out.
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.
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.
to the production and maintenance of study documents, ensuring template and
to how to Set-up, populate and accurately maintain information in AstraZeneca
tracking and communication tools (e.g. IMPACT, SharePoint, Archivex, etc)
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
additional country-specific tasks depending on country need.
Contrato: Beca de
1 año (6 meses + 6 meses)
De 9.00h a 18.00h
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
interpersonal skills and ability to work with other team members
and high ethical standards