Tasks & responsibilities

You will be responsible for the quality of our clinical studies in the field of data management. Your duties in detail:

• Implementation, monitoring and supervision of data management activities within assigned clinical trials, i.e. responsible to design, create, validate, review, approve and maintain data management tool specifications, including but not limited to: eCRFs and their set-up in EDC system, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and Data Management Plans (DMPs).
• Provision of adequate sponsor oversight of data management CROs or external data providers
• Filing and archiving of trial documentation
• Creation and execution of data quality checks throughout study conduct

You will drive and support process and system optimization in the capability management area.

• Partnering with business stakeholders to identify and evaluate business needs
• Participation in global development teams to support business objectives and uncover areas for continuous process improvement
• Mapping processes to system functionality and determining ways how to best implement the process, considering a healthy balance between system capabilities and process needs
• Driving and assisting the process of getting new business process models accepted and approved
• Creating and maintaining process documentation

Requirements

• Bachelor’s/ Master’s degree (e.g. MBA, MSc) in Life Sciences, Computer Science, Software/Computer Engineering, or related. Or high-qualified/multifaceted professional qualifications with relevant professional experience
• Understanding of dependencies among interfaces
• Experience in working in/with agile teams and/or as a product owner is a plus
• Ability to independent decision making, problem solving and ownership attitude
• Knowledge in and experience with the use of Data Collection Tools (EDC systems), Data Review Tools, and/or Data Standardization methods and requirements is a plus
• Understanding of CDISC standards (CDASH, SDTM, etc.…) is a plus
• Excellent communication and fluency in English in speaking and writing