Job Description

Overall Purpose of the job
CDR SPA will set up the Metadata Set-up Specification and Perform user acceptance testing (UAT) on clinical data following the company‘s SOP and processes to validate dataflow and derivations in clinical data repository.

- Attend the Protocol Kick off meeting and ecrf design Meeting.
- Set up Metadata Set-up Specification.
- Call MSS meeting and review items in the Agenda.
- Incorporate the changes to MSS document received from MSS review Meeting.
- Send MSS to PSP team to get Function names for the EPOCH Tab
- Turn on Business Rules per the Define.
- Create MSS TXT file and load it into CDR UI
- Create Mock Data plan
- Enter Mock Data in EDC collector and notify team
- Perform user acceptance testing (UAT) on clinical data following the company’s SOP and processes to validate data flow and derivations in clinical data repository. Review CDISC SDTM mapping of project specific data across various therapeutic areas.
- Once UAT is completed,
• Communicate to the team about the completion of your UAT.
• Make sure all your Test Scripts are completed.
• Create a PROD version of the MSS.
• Promote the metadata to production in the CDR UI.
- Use SAS v9 in a Windows XP environment to run SAS programs for UAT data extraction and verification.
Work with Statistician, Scientific Programmer, PSP, CDT, CDS PM, RAM Mapping, CS, TAS TL and Data Management to ensure readiness of data for analysis and reporting.

Educational and Experience Requirements :

Experience in the pharmaceutical industry, preferably in the Clinical Data Management or Statistical programming environment
• Knowledge of CDISC SDTM clinical data mapping
• Basic understanding of SAS and ability to run SAS programs to extract data
• Broad knowledge of Clinical Data Management including an understanding of data colle



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