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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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