Job Details

  • Title: Clinical Data Standards manager
  • Code: RCI-9792
  • Location: Berkeley Heights New Jersey (NJ) 07922
  • Posted Date: 09/16/2020
  • Duration: 12 Months
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  Job Description

  1. Developing and maintaining client clinical data standards and associated processes
  • Develop and maintain global clinical data standards, including operational (eCRF and external), Study Data Tabulation Model (SDTM), controlled terminology, external data mappings (e.g., lab or ECG), and other applicable standards. This would 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, and Clinical Data Interchange Standards Consortium (CDISC) controlled terminology.
  • Oversee or perform quality control on project and study metadata to assure adherence to global metadata standards.
  • Participate in or lead, as required, the development of systems and processes for creation and maintenance of data standards, including SDTM and other specifications, mappings between standards, and checking adherence to these data standards. Develop requirement documents for systems and programs.
  • Mentor project and study teams, as required, to ensure understanding of client clinical data standards and related processes. Support Project Standards Managers and Programmers in DOP in creation of new metadata that is consistent with the global data standards.
  • Coach CROs and vendors on client data standards and related processes.
  1. Participating in client’s Clinical Data Standards Governance Organization (CDSGO) as a contributor or annotator
  • Provide input and information to facilitate key discussions and decisions regarding standards use and implementation. May facilitate committees of client’s CDSGO, organizing standards topics to be reviewed and assuring decisions are made in a timely manner, documented in meeting minutes and other forms, and implemented.
  • May lead or facilitate various components of client’s CDSGO, including special-purpose working groups or committees.
  • Process clinical data change requests for new metadata including developing a GSM recommendation and implementation plan for the standard, as applicable, and assuring that the request is processed through the appropriate levels of the CDSGO.
  1. Other Key Activities
  • Lead or participate in the development of CDS SOPs, Working Procedures, and Guidance documents.
  • Participate in the identification, review, evaluation, and implementation of new technologies related to data standards.
  • May develop requirements for or develop programs for maintenance and/or validation of metadata.
  • Develop materials and provide training on CDS developed processes.
  • Ensure effective communication and collaboration between the CDS group and other functional groups impacted by clinical data standards.