Clinical Data Manager

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Boehringer Ingelheim
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November 04

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
Skill & Language
Management
4 - 6 years
Negotiation
1 candidate
December 06
Full Time
Management
Rheinfelden (Baden), Baden-Württemberg
Boehringer IngelheimPharmaceuticals Ingelheim am Rhein5 jobs · Biberach an der Riß, Baden-Württemberg
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Privately Held
1995
10001+ employees
About Company
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. Want to learn more? Visit www.boehringer-ingelheim.com and join us in our effort to make more health.
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