Clinical Study Administrator - Hamburg
- Germany
- Clinical Trial Support
- ICON Strategic Solutions
TA Business Partner
- Full Service Division
About the role
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
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Learn more about Our Culture at ICON
Day in the life
Teaser label
Inside ICONContent type
BlogsPublish date
01/26/2023
Summary
The CRO market has seen an unmistakable uplift in demand for its services in recent years. The call for personalised medicine, pricing pressures, and increasing complexity in clinical trials are j
Teaser label
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Teaser label
Inside ICONContent type
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Summary
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