The Clinical Study Administrator (CSA) assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives

ØCollects, assists in preparation, reviews and tracks documents for the application process as well as coordination and tracking of study materials and equipment

ØAssist in submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities

ØInterfaces with Investigators, external service providers and CRAs during the document collection process

ØLocal administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study

ØSet-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements

ØEnsures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Readiness” and study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF

ØPrepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts)

ØLeads the practical arrangements and contributes to the preparation of internal and external meetings. Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails

ØInterfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material

ØEnsures compliance with local, national and regional legislation, as applicable

• High school/Secondary school qualifications (*), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.
• Previous administrative experience preferably in the medical/ life science field.
• Proven organizational and administrative skills.
• Computer proficiency.
• Good knowledge of spoken and written German and English