Senior Manager, Clinical Data Standards

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Senior Manager, Clinical Data Standards, Bristol-Myers Squibb Company, Princeton, NJ. Develop, maintain and implement clinical data standards. Participate in the development and maintenance of global clinical data standards, including operational CDISC SDTM, controlled terminology, non-CRF standard data mappings (lab or ECG) and other applicable industry standards. Create metadata and mappings between the standards (operational and SDTM), and documentation of the use of the standard. 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 CDISC controlled terminology. Validate SDTM domains, which may include output from industry standard software tools and BMS custom validation programs. Work with standards management systems and software, such as MDR, Change Request Systems, SDTM validation systems and issues tracking systems. Communicate and reinforce content and interpretation of BMS 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, including developing a standards manager recommendation and implementation plan for the standard, as applicable, and ensure that the request is processed through the appropriate levels of the Central Drugs Standard Control Organization (“CDSCO”). Provide guidance to Study Teams and Submission Teams on SDTM standards and related submission requirements (SDTM annotated CRF, define.xml/pdf, Reviewer’s Guide and XPT files). Participate in the identification, review, evaluation and implementation of new technologies related to data standards.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $174,400 - 235,280/yr.   

MINIMUM REQUIREMENTS:

Master’s degree or foreign equivalent degree in Microbiology, Clinical Research, or a related life science field, and eight (8) years of post-baccalaureate experience.

In the alternative, the employer will accept a bachelor’s degree or foreign equivalent degree in Microbiology, Clinical Research, or a related life science field, and ten (10) years of post-baccalaureate experience.

Must have experience with/in:

• Clinical Trial Data,
• Pharmaceutical development process,
• Health Authority regulations,
• Good Clinical Trial (“GCT”) practice,
• Regulatory requirements,
• Clinical Data Interchange Standards Consortium (CDISC), Study Data Tabulation Model (“CDISC SDTM”), Collection (CDASH), Tabulation (SDTM) or analysis (ADaM) models,
• Define.xml,
• Medidata Rave electronic Data Capture (“EDC”),
• data mapping specifications,
• annotated CRFs,
• CRF design,
• data validation,
• Metadata
• Repository (“MDR”) and
• SAS.

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

May work remotely within normal commuting distance of Princeton, NJ.

To apply, email resume and reference R1592891 in the subject line of the email 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, ple