Senior Software Engineer- Medical Imaging

Senior Software Engineer - Medical Imaging ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. Position Summary The Senior Engineer, Clinical Trial Technology and Medical Imaging Applications is a specialized role within the Production Set-up team. This role is responsible for designing, developing, configuring, validating, and supporting project-specific analysis applications used to support clinical trial endpoints, medical imaging workflows, centralized review, and clinical research operations. The successful candidate must understand how clinical trial protocols, Independent Review Charters, imaging workflows, eCRFs, clinical databases, assessment criteria, sponsor requirements, and operational processes translate into reliable technology solutions that support global study execution. The ideal candidate combines deep expertise in clinical trial technology, medical imaging, software engineering, regulated SDLC practices, quality, regulatory expectations, and operational management. This individual must be able to independently prioritize work, make sound technical decisions based on study-specific needs, reduce technical debt, and ensure applications are fit for purpose for sponsors, sites, readers, adjudicators, data management, and operational teams. What You Will Do Clinical Trial Application Development Design, develop, configure, enhance, and maintain project-specific applications that support clinical trial endpoints, imaging review, operational workflows, and sponsor deliverables. Translate complex clinical, scientific, protocol, operational, and data requirements into technical specifications, application logic, workflows, reports, and user-facing functionality. Develop solutions that support medical imaging, centralized review, endpoint assessment, clinical data capture, study management, reader workflows, adjudication, and operational oversight. Partner with Production Set-up, Product, IT, Data Management, Quality, Clinical Operations, and sponsor-facing teams to ensure applications meet study needs and customer expectations. Support application modernization initiatives, workflow automation, reusable framework development, and reduction of legacy technical debt. Medical Imaging, Central Review, and Independent Review Workflows Develop and support systems used in support of: Blinded Independent Central Review, eligibility review, endpoint review, reader assignment, discrepancy management, adjudication, consensus workflows, and audit trail requirements. Review and interpret clinical trial protocols, imaging manuals, and Independent Review Charters to ensure application design aligns with study-specific endpoint definitions, assessment rules, review workflow, timing expectations, and blinding requirements. Support workflows for image transfer, de-identification, reconciliation, quality control, storage, viewing, measurement, review, archival, and data delivery. Ensure solutions support sponsor, site, reader, adjudicator, medical monitor, and operational management needs across global clinical studies. End-to-End Data Management Consistency Design technology solutions that enable consistent end-to-end data flow across protocol requirements, eCRFs, clinical databases, imaging platforms, assessment applications, operational reports, and sponsor deliverables. Ensure alignment between imaging data, clinical data, assessment results, reader decisions, adjudication outcomes, data exports, and downstream reporting outputs. Identify and mitigate data integrity risks, workflow gaps, traceability issues, duplicate data entry, manual reconciliation burden, and inconsistent endpoint reporting. Partner with Data Management and operational stakeholders to improve data mapping, edit checks, data review workflows, reconciliation processes, and study-specific standards. Support consistent application behavior across sponsor, study, therapeutic area, protocol, and criteria-specific requirements. SDLC, Quality, Validation, and Governance Lead and support all phases of the software development lifecycle, including requirements, solution design, development, testing, validation, UAT, deployment, release management, production support, and continuous improvement. Maintain traceability between protocol requirements, Independent Review Charter requirements, business requirements, functional specifications, technical design, test scripts, validation evidence, and training materials. Develop and maintain SDLC governance materials, technical documentation, SOP and work instruction inputs, training materials, knowledge repositories, and reusable standards. Support risk assessments, impact assessments, root cause analysis, CAPA activities, audit readiness, validation documentation, and regulated change control. Ensure systems and applications align with applicable quality and regulatory expectations, including GxP, GAMP 5, 21 CFR Part 11, ICH-GCP, EU Annex 11, HIPAA, GDPR, and internal quality requirements. Process Improvement and Operational Excellence Lead process improvement initiatives focused on quality, standardization, scalability, operational efficiency, delivery predictability, and reduction of rework. Identify workflow bottlenecks, hidden dependencies, technical debt, single-resource dependencies, knowledge gaps, and application risks that may impact study delivery. Develop reusable development standards, criteria-specific build standards, application templates, testing frameworks, training content, and operational playbooks. Support portfolio-level governance, prioritization, capacity planning, delivery tracking, and leadership reporting for project application development activities. Drive improvements that enable faster study start-up, stronger requirements clarity, consistent delivery, improved data quality, and better sponsor and stakeholder experience. Sponsor, RFI, and Cross-Functional Support Provide technical input for RFIs, sponsor assessments, client audits, demonstrations, solution design discussions, and feasibility reviews. Serve as a senior technical advisor to Production Set-up, Operations, Product, Quality, Data Management, and leadership teams. Communicate complex technical, clinical, imaging, and regulatory concepts clearly to technical and non-technical stakeholders. Mentor engineers and analysts, promote knowledge sharing, and strengthen team capability to reduce single-source dependency. Your Profile Required Qualifications and Experience Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Clinical Informatics, Information Systems, Life Sciences, or a related discipline. Advanced degree preferred. Significant experience in software engineering, clinical trial technology, medical imaging technology, healthcare technology, or regulated software development environments. Demonstrated experience supporting clinical research, CROs, pharmaceutical or biotechnology organizations, medical imaging providers, imaging core labs, centralized review organizations, or clinical technology vendors. Direct experience supporting centralized imaging review organizations and blinded independent review workflows, including BICR, endpoint adjudication, reader workflows, discrepancy resolution,