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Senior Global Standards Manager, Clinical Data Standards and Integration (CDSI)

Senior Global Standards Manager, Clinical Data Standards and Integration (CDSI)

The Senior Global Standards Manager within the Clinical Data Standards and Integration (CDSI) group will lead the development and maintenance of Celgene’s clinical data standards and related supportive processes.

Detailed Description

1. Leading the development and maintenance of Celgene clinical data standards and associated processes

  • Lead the development and maintenance of global clinical data standards, including operational (eCRF and external), post-process, the Study Data Tabulation Model (SDTM), controlled terminology, external data mappings (e.g., lab or ECG), and other applicable standards. This could include physical creation of the metadata and mappings between the standards, and documentation of the use of the standard.
  • Act as an expert on operational data standards, SDTM and/or Analysis Data Model (ADaM) standards, Clinical Data Interchange Standards Consortium (CDISC) controlled terminology, and standards-related submission requirements.
  • Oversee or perform quality control on project and study metadata to ensure adherence to global metadata standards.
  • Lead the development of systems and processes for creation and maintenance of data standards, including specifications, mappings between standards, and checking adherence to these data standards. 
  • Develop requirements documents for systems and programs.
  • Mentor project and study teams to ensure understanding of Celgene clinical data standards and related processes. Support Project Standards Managers and Programmers in creation of new metadata that are consistent with the global data standards.
  • Coach CROs and vendors on Celgene data standards and related processes. 

2. Participating in Celgene’s Clinical Data Standards Governance Organization (CDSGO) as a leader, facilitator, and annotator

  • Facilitate and lead committees of the CDSGO, organizing standards topics to be reviewed and ensuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented. Provide input and information to facilitate key discussions and decisions regarding standards use and implementation.
  • Lead or facilitate various components of Celgene’s CDSGO, including special-purpose working groups or committees.
  • Oversee or process clinical data change requests for new metadata, including developing a GSM recommendation and implementation plan for the standard, as applicable, and ensuring that the request is processed through the appropriate levels of the CDSGO.

3. Other Key Activities

  • Lead or participate in the development of CDSI SOPs, Working Procedures, and Guidance documents.
  • Lead or participate in the identification, review, evaluation, and implementation of new technologies related to data standards. 
  • Develop materials and provide training on CDSI-developed processes.
  • Ensure effective communication and collaboration between the CDSI group and other functional groups impacted by clinical data standards.
  • May coach more junior personnel or contract staff, as required.
  • Lead or participate in special projects as assigned.
  • Develop solutions and share best practices as required.

Location New Jersey 

URL to Listing http://jobs.celgene.com/ShowJob/Id/1092055/Senior-Global-Standards-Manager,-Clinical-Data-Standards-and-Integration-(CDSI)/