Standards and CDM Analyst

Description

1. Review clinical study data requirements and eCRFs to identify new and/or modified data elements2. Participate in study team meetings, during the study startup phase, and coordinate the definition and creation of new data elements and forms with Clinical Systems, Statistical Programming, and Data Management while adhering to FRI standards. 3. Serve as a Standards liaison with study team members and advocate, whenever possible, the use of FRI standards. 4. Compare annotated eCRFs with the FRI Data Dictionary and provide updates to the dictionary to accommodate new or expanded CRF specifications. 5. Annotated and define, according to FRI standards, any new data elements that are required.6. Ensure that final annotated eCRFs are compliant with FRI standards7. Ensure that final eCRF components are defined within the FRI data dictionary8. Provide additions and enhancements to the FRI Standards library9. Review annotated eCRFs with regard to the Submission Data Tabulation Model (SDTM) application and modify the metadata to accommodate new or expanded modules. 10. Participate in eCRF and edit check design, 11. Perform user acceptance testing on database and data transfers.12. Validate clinical data13. Perform SAE reconciliation between the clinical database and the Drug Safety database