Clinical Data Specialist - SDTM, ADaM, CDASH in Pleasanton, CA at Apex Life Sciences

Date Posted: 8/10/2018

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Job Description

Apex Life Sciences is seeking a Clinical Data Specialist to lead clinical data standardization efforts for Clinical Operations and Biometrics within the Pharmaceutical industry.


  • 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.


  • Bachelors 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)
  • May be asked to travel domestically approximately 5% of time with occasional international travel as necessary.

***For immediate consideration, please email your updated resume to with 'Clinical Data Specialist SDTM' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or 844-463-6178.