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We are hiring a Clinical Data Specialist to be located in the East Bay of CA!

Oakland-Fremont-Pleasanton Metro Area, CA

Post Date: 07/10/2018 Job ID: JN -072018-22020 Job Type: Clinical
  • Review study protocols and identify variables to be standardized, using expertise in CDASH and SDTM standards published by CDISC.
  • Request new standard variables to enhance DIA clinical data standards, and ensure full adherence on study level.
  • Review and approve standard variable proposals
  • Define clinical data standard catalogues.
  • Train study team members on DIA data standardization processes.
  • Work closely with Data Management to ensure data standards are adopted in EDC study configuration.
  • Work closely with Global Data Standards Manager and Information Architect to enhance training material on data standardization.
  • Provide adherence to data standards results to stakeholders (e. g. Study Teams, CLOC).
  • Analyze data standards adherence and define means to improve it.
  • Monitor releases of Standard Development Organizations (e. g. CDISC).
  • Support the adoption of external standards.
  • Clearly and effectively communicate changed processes to affected groups and leadership.
  • Develop and maintain knowledge base for DIA data standards.
  • Bachelor s degree in Life Sciences, Data Science, Computer Science, a related scientific field or equivalent work experience.
  • At least 5 years of data standardization experience using standards provided by CDISC.
  • Experience in working with Data Management team to drive implementation of data standards.
  • Experience and thorough understanding of the Clinical Trial Process, specifically in Clinical Data Management, CRF development and data collection, review and handling best practices.

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