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

Oakland-Fremont-Pleasanton Metro Area, CA

Posted: 08/30/2018 Job Type: Clinical Job Number: JN -082018-22441
RESPONSIBILITIES:
  • Review COBM 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 raised by other BA representatives.
  • 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.

REQIUREMENTS:

  • 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.
  • Experience analyzing and solving business situations.
  • Experience presenting information to diverse audiences.
  • Project Management
  • Comprehensive understanding of clinical development process.
  • Must be detail oriented.
  • Able to simplify a complex set of components into a simple, effective message or communication plan. Strong executive presentation skills and writing skills
  • Demonstrate ability to develop and present sound proposals and recommendations. Brings experience in implementing and embedding solutions, not just information-gathering to management.
  • Knowledge of industry standards as it applies to the collection, tabulation and analysis of study data
  • Good knowledge of international health regulations, ICH, GxP, CSV guidelines.
  • In-depth knowledge of clinical data standards (CDISC CDASH, SDTM, Controlled Terminology).

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