Clinical Data Specialist

Location: Pleasanton, CA, United States
Date Posted: 07-13-2018
Position Role/Tile: Clinical Data Specialist
Location:  Pleasanton, CA​​.

Job Description:

Lead clinical data standardization efforts for Clinical Operations and Biometrics (COBM) organization, within Molecular Solutions. The job holder ensures that the interface to the study teams is in place and that the study team members are trained and instructed in the application of the DIA clinical data standards (best practices).
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.
Formal Training/Education:
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.
Knowledge, Skills, and Abilities:
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).
Approximately 5% of domestic travel required with occasional international travel as necessary.

Central Business Solutions, Inc,
37600 Central Ct.
Suite #214
Newark, CA 94560.
Central Business Solutions, Inc(A Certified Minority Owned Organization)
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Central Business Solutions, Inc
37600 Central Court Suite 214 Newark CA, 94560
Phone: (510)-713-9900, 510-573-5500 Fax: (510)-740-3677
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