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GRGreiner Bio-One GmbH

Expert Clinical Data Management(m/w/x)

Kremsmünster
from 59,781.96 / year
Full-timeOn-siteExperienced

Designing and implementing clinical trial data management processes, including EDC systems and eCRFs, for medical devices. Technical writing experience in medical/pharma and IVD/MD regulatory knowledge strongly preferred. Direct collaboration with project managers and statisticians.

Requirements

  • Master's degree in life sciences or equivalent academic/vocational qualification
  • Technical writer experience for medical/pharma company with high attention to detail
  • Strongly preferred experience with IVD/MD regulatory landscape
  • Preferred but not required experience with MD/IVD trials
  • Preferred but not required experience in validation
  • Effective verbal and written English communication
  • Independent and reliable work managing multiple tasks/priorities in fast-paced international environment

Tasks

  • Set up data management processes for clinical trials
  • Create or select appropriate EDC systems
  • Create or select non-EDC data transfer tools
  • Create or review trial-specific eCRFs
  • Collaborate with project managers and statisticians
  • Support data cleaning and statistical evaluation
  • Configure EDC databases
  • Migrate EDC databases
  • Test EDC databases
  • Attend trial-specific team meetings
  • Generate status reports and metrics
  • Review clinical data
  • Generate and close data queries
  • Define data management process interfaces
  • Train colleagues in clinical data management

Work Experience

  • approx. 1 - 4 years

Education

  • Vocational certification

Languages

  • EnglishBusiness Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Greiner Bio-One GmbH and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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