Manager, Clinical Data Standards

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Manager, Clinical Data Standards, Bristol-Myers Squibb Company, Princeton, NJ. Manage activities associated with consistent implementation of global clinical data standards for projects and studies and assist in leading the development and maintenance of company’s global clinical data standards and related supportive processes. Develop and maintain global clinical data standards, including operational (Case Report Form (CRF) and non-CRF) Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM), controlled terminology, non-CRF standard data mappings and other applicable industry standards. Participate in relevant study team meetings as standards subject matter expert and provide input for standards components, such as CRF design, CRF Completion Guidelines, Programmed edit checks, Data transfer specifications, SDTM mapping specifications and SDTM annotated CRF. Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology. Consult study teams on validation of SDTM domains. Coach CROs and vendors on company’s data standards and related processes. Communicate and reinforce content and interpretation of company’s data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project. Process clinical data change requests for new or existing metadata, ensuring that the request is processed through the appropriate levels of the CDSGO. Participate in the committees of the CDSGO, partner with functional area stewards, organizing standards topics to be reviewed. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements, (e.g., SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide, XPT files). Develop CDSIC or cross functional SOPs, Working Procedures, Guidance documents, and job aids. Work on identification, review, evaluation, and implementation of new technologies related to data standards. Develop training materials and provide training on CDS-developed processes. Coach more junior personnel or contract staff. (R1592888)

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $161,470 - $194,270/yr.

MINIMUM REQUIREMENTS:

Master’s degree or foreign equivalent degree in Computer Information Systems, Computer Science, Health Science, or a related field, and five (5) years of post-baccalaureate related work experience.

In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent degree in Computer Information Systems, Computer Science, Health Science, or a related field plus seven (7) years of post-baccalaureate related work experience.

Must have experience with/in:

• CDISC Industry Standards (SDTM, ADaM, CDASH),
• Medidata Rave (EDC) and Metadata Repository (MDR), and
• SAS programming.

The required skills do not need to be maintained over the full term of required experience.

Any suitable combination of education, training or experience is acceptable.

To apply, email resume and reference R1592888 to resume.com@bms.com.

The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.

Benefit offerings are subject to the terms an