Clinical Data Standards Specialist Full-time Job

To lead and participate in the development and maintenance of Signant Health’s global clinical data standards, including CRF CDISC Study Data Tabulation Model (SDTM), controlled terminology, and other applicable industry and customer standards Participate in relevant team meetings as SME for standards and provide input for data standards to customers and internal stakeholders (Business Development, Medical/Clinician, Product, R&D, etc.), such as eCRF design, data transfer specifications, SDTM mapping, edit checks, etc. Work with and participate in the implementation of a Clinical Data Management System (CDMS), which may include the development of a clinical metadata repository, and data validation checks Design and maintain discrepancy management system Author core data management templates: Data Management Plan (DMP), Data Transfer Specifications (DTS) and Data Review Plan (DRP) Participate in regulatory agency and internal audits as necessary