IT Subject Matter Expert (ITSME) – eSource System Integration

Job Title: IT Subject Matter Expert (ITSME) – eSource System Integration

• Location: Indianapolis, IN

• Duration: 6 months

• Experience Required: 8–10 years

• Primary Focus: Clinical Development IT, eSource Integration, EHR-to-EDC Integration

• Keyword: 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.