Senior Software Engineer – Medical Imaging

🔥 0 minutes ago

🗽 New York, Pennsylvania – Remote

🗽 New York – Remote 🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧑‍💻 Full-stack Engineer

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Design, develop, configure, enhance, and maintain project-specific applications supporting clinical trial endpoints, imaging review, operational workflows, and sponsor deliverables • Translate clinical, scientific, protocol, operational, and data requirements into technical specifications, application logic, workflows, reports, and user-facing functionality • Develop and support systems for blinded independent central review, eligibility review, endpoint review, reader assignment, discrepancy management, adjudication, consensus workflows, and audit trails • Support image transfer, de-identification, reconciliation, quality control, storage, viewing, measurement, review, archival, and data delivery workflows • Design solutions enabling consistent end-to-end data flow across protocols, eCRFs, clinical databases, imaging platforms, assessment applications, operational reports, and sponsor deliverables • Lead and support requirements, solution design, development, testing, validation, UAT, deployment, release management, production support, and continuous improvement • Maintain traceability across protocol requirements, Independent Review Charters, business requirements, specifications, technical design, tests, validation evidence, and training materials • Support risk assessments, impact assessments, root cause analysis, CAPA activities, audit readiness, validation documentation, and regulated change control • Lead process improvement initiatives focused on quality, standardization, scalability, efficiency, predictable delivery, and reduced rework • Develop reusable development standards, build standards, application templates, testing frameworks, training content, and operational playbooks • Provide technical input for RFIs, sponsor assessments, client audits, demonstrations, solution design discussions, and feasibility reviews • Serve as a senior technical advisor to cross-functional teams and leadership • Mentor engineers and analysts and promote knowledge sharing • Act as a senior technical contributor and domain expert for project-specific clinical trial application builds • Identify delivery risks, technical gaps, process inefficiencies, and modernization opportunities • Support reliable, traceable, end-to-end data management from study setup through review, adjudication, reporting, and delivery • Travel approximately 15% as required for business, sponsor, audit, training, or project needs

🎯 Requirements

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Clinical Informatics, Information Systems, Life Sciences, or a related discipline • Significant experience in software engineering, clinical trial technology, medical imaging technology, healthcare technology, or regulated software development environments • 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, and imaging review operations • Experience translating clinical trial protocols, imaging manuals, Independent Review Charters, data collection requirements, and sponsor requirements into application functionality and technical solutions • Experience with medical imaging, centralized review, endpoint assessment, clinical data capture, data reconciliation, and operational reporting systems • Strong experience with regulated SDLC, validation, quality, and change control frameworks • Ability to independently assess competing priorities and make decisions based on study-specific risk and operational need • Python, Java, SQL, REST APIs, JavaScript or related web technologies, database design, application architecture, workflow automation, source control, CI/CD, and release management • BPM or workflow orchestration experience required • Experience with EDC, eCRF design, clinical databases, clinical data review systems, CTMS, study management tools, operational reporting, data exports, and clinical data integrations • Experience with DICOM standards, image transfer workflows, imaging archives, imaging viewers, image QC, reader platforms, annotation and measurement tools, central review platforms, and AI-enabled imaging solutions • Computer System Validation, risk-based validation, UAT, traceability matrices, test scripts, validation evidence, audit trails, GxP, GAMP 5, 21 CFR Part 11, ICH-GCP, EU Annex 11, HIPAA, and GDPR • Working knowledge of imaging and endpoint assessment criteria across therapeutic areas • Willingness to travel approximately 15% • Legal right to work in the country where the role is based • Advanced degree preferred • Camunda BPM experience strongly preferred • Experience with AI-assisted imaging analysis, quantitative imaging, segmentation, volumetric analysis, radiomics, or machine-learning-enabled imaging workflows in regulated clinical research environments preferred • 8+ years of experience supporting imaging CROs, medical imaging core labs, independent review organizations, eClinical technology providers, or clinical trial technology vendors preferred • Experience with sponsor-facing solution design, technical feasibility assessment, RFI/RFP support, client audits, and regulatory inspection support preferred • Experience leading modernization initiatives, workflow automation, technical debt remediation, and process improvement preferred • Experience mentoring technical team members and building organizational knowledge management practices preferred

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Reasonable accommodations during the recruitment process • Flexible Office or Home work arrangement