We are hiring a Clinical Data Standards Specialist to be located in the East Bay of CA!
Oakland-Fremont-Pleasanton Metro Area, CA
- 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.
- 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).