Expert Clinical Data Management

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...

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

Your profile

• Master’s degree in a life sciences-related field or equivalent and relevant formal academic / vocational qualification. 
• Experience as a technical writer or equivalent for a medical device or pharmaceutical company demonstrating high attention to detail
• Experience with regulatory landscape for IVDs and MDs is strongly preferred
• Experience with MD and/or IVD trials is preferred but not required 
• Experience in validation preferred, but not required
• Effective and appropriate verbal and written communication in English with internal and external stakeholders, locally and globally
• Ability to work independently and reliably in managing multiple project tasks and priorities and in a fast-paced and changing international environment 

Our offer

We offer you an exciting and independent ...