Clinical Data Manager at Centre for Human Drug Research
Clinical Data Manager (32-40 hours a week)
About the organization
CHDR is an independent institute specialising in innovative, early-stage clinical drug research (www.chdr.nl). By combining cutting edge methods and technologies, state-of-the-art facilities, we help maximize our clients’ success. We are located in Leiden, the Netherlands, and collaborate closely with the University of Leiden and the clinical departments of the LUMC.
What does the job look like?
As a Clinical Data Manager, you would
Perform edit checks of clinical study protocols on developed databases both manually and via test scenario’s (UAT) before the database is being released
Contribute to the development of data management plans associated with study protocols
Check incoming data from clinical trials on oddities/deviations towards the study protocol (quality control checks)
Prepare monitor visits with the Project Lead and act as the main contact person for data queries of monitors
Monitor the progress of data transfers and/or data transfer queries by the Data Entry Officers
Perform relevant and agreed end/interim checks and progress reports to ensure the data base is complete and in line with the protocol requests before being locked to be shared with the clients
Co-develop and test new procedures regarding data management following feedback from monitors, trend/market developments and/or as part of the continuous improvement cycle
The job requires:
A bachelor’s degree or equivalent or relevant experience
Excellent knowledge of data management processes in clinical trials
Working accurately and structurally with effective communication and analysis skills.
An experience in CRF annotation for SDTM process is preferred
An experience on edit checks testing in UAT environment is preferred
Good command of English is preferred
Other competencies would include the ability to work independently, to plan and to work within a strict timeframe.
You will join a dynamic, passionate organization and work within a small team in a multi-disciplinary environment. In addition to a competitive salary, we offer good secondary employment conditions such as a development opportunities, an end of year bonus and all kinds of social events.
Want to apply?
Send your application in Dutch or English with CV to our HR Department via: email@example.com.