IT Subject Matter Expert (ITSME) – eSource System Integration

Job Title: IT Subject Matter Expert (ITSME) - eSource System Integration Location: Indianapolis, INDuration: 6 monthsExperience Required: 8-10 yearsPrimary Focus: Clinical Development IT, eSource Integration, EHR-to-EDC IntegrationKeyword: Generative AI Essential Skills Experience integrating electronic medical records (EMR/EHR) with Electronic Data Capture (EDC) systems. Knowledge of eSource platforms, including eCOA/ePRO, eConsent, wearables, sensors, and site-facing source capture tools. Experience with IgniteData Archer or similar EHR-to-EDC integration solutions. Strong understanding of REST APIs, HL7 FHIR, event-driven messaging, and file-based interfaces. Experience with application support and IT service management. Knowledge of Incident, Problem, Change, Configuration, and Request Management. Experience with access management and administration. Experience creating and maintaining requirements, test scripts, and traceability matrices. Knowledge of GxP, Computerized System Validation (CSV), and regulatory compliance. Understanding of 21 CFR Part 11, EU Annex 11, audit trails, and ALCOA+ data integrity principles. Experience with CI/CD pipelines, infrastructure as code, and release automation. Strong technical documentation, troubleshooting, and stakeholder communication skills. Key Responsibilities Design, develop, and maintain integrations between eSource platforms and downstream clinical systems, including EDC, CTMS, and clinical data repositories. Provide technical consultancy for EMR-to-EDC integration services using IgniteData Archer and similar solutions. Understand Archer’s mapping engine and its role in securely transferring data from EHR workflows to EDC systems. Analyze integration requirements and recommend appropriate technical solutions. Perform impact analysis, requirements gathering, testing, deployment, and verification/validation of third-party products. Maintain CI/CD pipelines, infrastructure-as-code configurations, and release automation. Ensure integration solutions comply with GxP and computerized system validation requirements. Manage integration incidents, perform root cause analysis, and implement corrective and preventive actions. Support Incident Management, Problem Management, Change Management, Configuration Management, Request Fulfillment, and Access Management. Create and maintain requirements documentation, test scripts, traceability matrices, and validation packages. Ensure validation documentation aligns with Lilly Quality guidelines. Develop and maintain testing packages, API specifications, technical documentation, and interface catalogs. Coordinate with Clinical Operations, Data Management, customers, and vendors. Evaluate new eSource technologies for technical suitability, risk, and roadmap alignment. Regulatory and Compliance Skills Good Clinical Practice (GCP) and GxP compliance. Computerized System Validation (CSV). 21 CFR Part 11. EU Annex 11. ALCOA+ data integrity principles. Audit trail management and traceability. Validated environment management and controlled releases. Desirable Skills Experience with IgniteData Archer. Clinical Development IT and clinical trial technology integration. EHR, EMR, EDC, and CTMS systems. SAS technology. Generative AI (GenAI). Siebel architecture or related technologies. Vendor management and service delivery. Experience working in regulated pharmaceutical environments. Core Competencies Software engineering discipline and systems thinking. Strong integration architecture and troubleshooting skills. Regulatory rigor and validation documentation. Vendor and stakeholder management. Clear technical communication and documentation. Ability to translate clinical study requirements into reliable, compliant integration solutions. Role Summary Serve as the technical subject matter expert for eSource and EHR-to-EDC integrations. Support clinical data integration using IgniteData Archer and similar platforms. Manage application support, service management, testing, and validation activities. Ensure secure, reliable, traceable, and compliant clinical data exchange across systems.