Your challenge

• Set up of Data Management Processes for clinical trials for MDs and IVDs incl. creation and/or selection of an appropriate EDC system as well as non-EDC based data transfer tool
• Create and/or review of trial-specific (e) Case Report Forms (CRFs) according to clinical trial plan and clinical team input in a timely manner
• Work in close cooperation with the clinical project manager and statistician for efficient data cleaning and statistical evaluation on the course of the trial (spot checks), during interim analysis as well as trial closure
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, trial requirements, and system best practices
• Attend trial-specific team meetings and produce status reports and requested metrics, which may include query information or data trends
• Perform data review and query generation/closure
• Participate in the definition of interfaces between data management and existing processes and train colleagues in clinical data management as required
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