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Senior Manager, Clinical Data Standards & Integration

Senior Manager, Clinical Data Standards & Integration

The Senior Project Standards Manager within the Clinical Data Standards and Integration (CDSI) group will manage the activities associated with the consistent implementation of clinical data standards.

Detailed Description

1.Operational Support for Implementation of Celgene Data Standards

  • Independently develop and maintain project data standards, considering the needs of individual studies within the project, while following Celgene global data standards. Make decisions in conjunction with Global Standards Manager(s) regarding when project data standards can and should deviate from Celgene global data standards. Data standards will include, but not be limited to, the CDISC Study Data Tabulation Model (SDTM), Controlled Terminology, or other relevant, current industry standards models. 
  • Provide input into individual study deliverables with data standards components, including:
  • CRF design, ensuring consistent CRF standards (including metadata) are used for all studies in a project
  • CRF Completion Guidelines, to ensure consistency across studies within a project in how and when CRFs are completed
  • Programmed edit checks, to ensure consistency across the studies within a project
  • Data transfer specifications, to ensure consistency across the project in external data structure to facilitate mapping to the SDTM standard
  • SDTM mapping specifications and SDTM annotated CRF, to ensure consistent SDTM mapping for studies within a project
  • Work with standards management systems and software, such as Metadata Repository, OpenCDISC, and issues tracking systems. 
  • Act as a consulting resource for study teams regarding the validation of SDTM domains, which may include output from software tools such as OpenCDISC and Celgene custom validation programs.
  • Communicate and reinforce content and interpretation of Celgene data standards to project and study teams, to ensure consistency in understanding and implementation of standards across a project.
  • Act as the key point of contact for project specific standards implementation issues.
  • 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.
  • Provide input into project and study timelines and vendor contractual agreements.
  • Participate in project and study team meetings as needed, specifically in a supportive capacity.
  • Coach CROs and vendors on Celgene data standards and related processes.
  • Provide standards support to multi-project development programs, including early strategic assessments.


2. Standards Support for Submissions

  • Provide leadership and guidance to Submission Team regarding overall project strategy related to data standards for regulatory filings, including how data are to be submitted, the format in which individual studies are to be submitted, and what version of the coding dictionaries are to be used.
  • Work with the Submission Team to prepare regulatory correspondence regarding submission standards.
  • 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).
  • Act as a consulting resource for study teams regarding the validation of eCRT/define packages.
  • Participate in submission team meetings.

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