CDMS Support for eSOurce(CRIO Direct Data Capture and EMR to EDC) Consultant

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• eSource Post Go-live Monitoring Support

Track and monitor mapped EMR fields across sites using existing CDMS reports and CDB autochecks (hypercare for newer trials) Work with Reporting SMEs to build any additional study specific reporting tools focused on API vendor accounts Summarize reporting tool options, when to utilize them, and help educate eSource team members on their availability Help ensure API connections are verified after PPC study changes to ensure integrations do not break

• UAT & Site Testing Support

Assist with defined UAT process based on sites/site networks and data domains in scope Work with study build/eSource personnel and Tech @ Lilly to ensure that test scripts are successfully executed and documented for each site or site network ahead of PRD API or site user access requests

• Vendor & Platform Release Testing and/or Supporting Tool Evaluations

Support UAT testing cycles for Veeva and eSource vendor releases Execute UAT regression testing under defined test plans Document results and escalate failures appropriately Assist Tech@Lilly with CDMS environment API connection testing as needed if parallel connections cannot be supported by the vendor Support evaluation of new eSource vendors to understand platform functionality and differences between middleware capabilities/API endpoint utilization Review of any tools providing automated review of vendor build templates to EDC study shell for understanding and/or gaps in content review

• eSource Study Initiation Surge Support

Provide surge capacity when multiple eSource studies enter build concurrently Attend study and status meetings as necessary when CRF-CRS staff are unable to attend. Prepare validation artifacts and checklists as needed

• Routine Escalation & Triage (NonCritical)

Act as firstline support for routine eSource testing and validation questions Filter and escalate only highrisk or ambiguous issues to CRS SMEs Prepare summary slides to help communicate issues and impact given varying levels of technical understanding with CDMS functionality

• Integration Support Activities

Provide support for CDMS integration activities as needed especially for those efforts using APIs or sFTP accounts Atom5 (Kyle Durics said Cork are getting a new Atom5 resource so that will assist in collaboration too)

• Inspection Readiness Activities

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