| Location | Indianapolis, IN |
The eSource Technical Subject Matter Expert (SME) is responsible for delivering technical expertise for eSource systems (Electronic Medical Records / Direct Data Capture) to support eData capture initiatives, drive efficient and compliant clinical trial operations, and ensure high-quality data deliverables. The SME serves as the central technical authority aligning system capabilities, clinical data management needs, regulatory requirements, and vendor delivery.
eSource Technical Ownership: Serve as the primary Technical Subject Matter Expert (SME) for eSource, Electronic Medical Records (EMR), Direct Data Capture (DDC), and Electronic Data Capture (EDC) platforms such as Medidata/ Veeva EDC
Verification & Validation: Oversee end-to-end verification and validation of third-party vendor capabilities and eSource/EMR integration solutions, ensuring strict alignment with quality, regulatory, and technical standards.
Compliance & Standards Alignment: Conduct technical evaluations of vendor deliverables and clinical data capture tools to ensure adherence to corporate standards and clinical processes.
Backlog & Feature Prioritization: Manage and prioritize the product backlog for eSource system enhancements, serving as the central liaison between business stakeholders and external technology vendors.
System Maintenance: Manage post-production technical support, post-go-live changes, and structural updates to ensure continuous system operational readiness.
Cross-Functional & Vendor Liaison: Act as the primary technical bridge between business owners, clinical data management teams, and third-party vendors.
eSource & Clinical Data Platforms: Deep knowledge and hands-on technical experience with EDC systems (e.g., Oracle InForm, Veeva Vault EDC/CDMS), EMR/EHR platforms (e.g., Epic, Oracle Health), and DDC solutions (e.g., Veeva Vault eSource, TrialKit, ClinCapture).
Validation & Compliance: Hands-on experience in verification, validation, and software lifecycle compliance within regulated clinical/pharma environments.
Agile Backlog Management: Proven ability to manage product backlogs, prioritize feature enhancements, and lead cross-functional requirement sessions.
Vendor & Stakeholder Management: Excellent collaboration skills to interface effectively between business owners, technical engineering teams, and third-party technology providers.