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Job description below
IT Subject Matter Expert (ITSME), eSource System Integration, Clinical Development IT
Role Summary
The ITSME is the technical authority for integrating eSource systems (eCOAePRO, eConsent, EHR-to-EDC connectors, wearables and sensor platforms, and site-facing source capture tools) into the clinical development data landscape. The role designs and builds the interfaces that move source data reliably, compliantly, and with full traceability from point of capture to downstream systems such as EDC, CTMS, and the clinical data repository.
Key Responsibilities
Design and develop integrations for eSource platforms using REST APIs, HL7 FHIR, event-driven messaging, and file-based interfaces, applying sound software engineering practices (modular design, versioning, code review, and reusable components).
Affect impact analysis, requirements, testing, deployment, and verificationvalidation of related third-party productssolutions.
Maintain CICD pipelines, infrastructure-as-code, and release automation for interfaces, supporting controlled promotion through validated environments.
Ensure solutions meet GxP and computerized system validation requirements, including 21 CFR Part 11, EU Annex 11, audit trails, and data integrity (ALCOA+).
Act as escalation for integration incidents, performing root cause analysis and delivering fixes and preventive improvements.
Partner with Clinical Operations, Data Management, and vendors to translate study requirements into technical specifications, and evaluate new eSource technologies for fit, risk, and roadmap.
o Maintain technical documentation, API specifications, and interface catalogs as applicable.
Core Competencies
Software engineering discipline, systems thinking, regulatory rigor, vendor and stakeholder communication, and clear technical documentation.
Role Descriptions: Technology SAS, GenAI, SeibelRole Architect, Technology integration. Associate will provide technical consultancy for EMR (electronic medical records) to eDC services workstream utilizing IgniteData Archer and similar solutions. Archer is a cloud-based application with a complex mapping engine that bridges EHR (Electronic Health Records) and EDC (Electronic Data Capture). It acts as a secure data processor that embeds itself within the EHR workflow.Responsibility Application support and Service Management with focus on Incident Management, Problem Management, Change Management, Configuration Management, Request Fulfillment, and Access Management Admin activities, creation and maintenance of requirements, test scripts, and traceability matrix. Creation and maintenance of validation package with alignment to Lilly Quality guidelines. Creation and maintenance of testing packages. Communication and coordination with customers and vendors for day-to-day activities. Understand integration and consult on solutions.
Essential Skills: Technology SAS, GenAI, SeibelRole Architect, Technology integration. Associate will provide technical consultancy for EMR (electronic medical records) to eDC services workstream utilizing IgniteData Archer and similar solutions. Archer is a cloud-based application with a complex mapping engine that bridges EHR (Electronic Health Records) and EDC (Electronic Data Capture). It acts as a secure data processor that embeds itself within the EHR workflow.Responsibility Application support and Service Management with focus on Incident Management, Problem Management, Change Management, Configuration Management, Request Fulfillment, and Access Management Admin activities, creation and maintenance of requirements, test scripts, and traceability matrix. Creation and maintenance of validation package with alignment to Lilly Quality guidelines. Creation and maintenance of testing packages. Communication and coordination with customers and vendors for day-to-day activities. Understand integration and consult on solutions.
Desirable Skills:
Keyword:
Skills: Generative AI
Experience Required: 8-10
