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
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
Skill & Language
4 - 6 years
Rheinfelden (Baden), Baden-Württemberg
Boehringer IngelheimPharmaceuticals Ingelheim am Rhein5 jobs · Biberach an der Riß, Baden-Württemberg
OverviewAt Boehringer Ingelheim we create value through innovation with one clear goal: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We are powered by 52.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key, because your growth is our growth.
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