Senior Software Engineer- Medical Imaging

IRE • Rochester, NY

4d • Remote

About The Position

ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the delivery of new medicines and treatments to patients. As a values-driven organisation, integrity, collaboration, agility, and inclusion are central to our operations. The Senior Engineer, Clinical Trial Technology and Medical Imaging Applications is a specialized role within the Production Set-up team, responsible for designing, developing, configuring, validating, and supporting project-specific analysis applications. These applications are crucial for clinical trial endpoints, medical imaging workflows, centralized review, and clinical research operations. The role requires a deep understanding of how clinical trial protocols, Independent Review Charters, imaging workflows, eCRFs, clinical databases, assessment criteria, sponsor requirements, and operational processes translate into reliable technology solutions for global study execution. The ideal candidate possesses expertise in clinical trial technology, medical imaging, software engineering, regulated SDLC practices, quality, regulatory expectations, and operational management, with the ability to independently prioritize work, make sound technical decisions, reduce technical debt, and ensure applications are fit for purpose for all stakeholders.

Requirements

• 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, and imaging review operations.
• Experience reviewing and translating clinical trial protocols, imaging manuals, Independent Review Charters, data collection requirements, and sponsor requirements into application functionality and technical solutions.
• Experience supporting systems or applications used for medical imaging, centralized review, endpoint assessment, clinical data capture, data reconciliation, and operational reporting.
• Strong experience working within regulated SDLC, validation, quality, and change control frameworks.
• Ability to independently assess competing priorities, make decisions based on study-specific risk and operational need, and deliver high-quality technical solutions with limited oversight.
• Programming and Engineering: Python, Java, SQL, REST APIs, JavaScript or related web technologies, database design, application architecture, workflow automation, source control, CI/CD, and release management.
• Workflow and BPM: BPM or workflow orchestration experience required; Camunda BPM experience strongly preferred.
• Clinical Trial Systems: EDC, eCRF design, clinical databases, clinical data review systems, CTMS, study management tools, operational reporting, data exports, and clinical data integrations.
• Medical Imaging Systems: 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.
• ICON-Relevant Technology Context: Experience applicable to Production Set-up and project application build environments, EDC/eCRF/database integrations, workflow automation, criteria-specific application standards, and sponsor-specific study configurations.
• Validation and Compliance: 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.
• Data and Reporting: Data mapping, data reconciliation, edit checks, endpoint data consistency, data exports, operational dashboards, sponsor reporting, and downstream data delivery standards.
• Working knowledge of imaging and endpoint assessment criteria across therapeutic areas is strongly preferred, including but not limited to: Oncology: RECIST 1.1, iRECIST, irRECIST, mRECIST, Lugano, Cheson, LYRIC, RANO, PCWG3, and volumetric assessments. Cardiac assessments, including quantitative imaging endpoints and study-specific measurement rules. MSK, GI, Neuro, and other specialty imaging workflows and criteria-specific review methodologies.
• AI-assisted imaging analysis, quantitative imaging, segmentation, volumetric analysis, radiomics, or machine learning enabled imaging workflows in regulated clinical research environments preferred.
• Willingness to travel as required, approximately 15%, based on business, sponsor, audit, training, or project needs.

Nice To Haves

• 8 + years of experience working for or supporting imaging CROs, medical imaging core labs, independent review organizations, eClinical technology providers, or clinical trial technology vendors.
• Experience with sponsor-facing solution design, technical feasibility assessment, RFI/RFP support, client audits, and regulatory inspection support.
• Experience creating or maintaining criteria-specific standards, reusable build components, study configuration standards, application design patterns, and operational training materials.
• Experience leading modernization initiatives, workflow automation, technical debt remediation, and process improvement within clinical trial technology environments.
• Experience mentoring technical team members and building organizational knowledge management practices.

Responsibilities

• 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.
• Develop and support systems for 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.
• 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.
• 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.
• 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.
• 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.
• Ensure solutions are aligned with protocols, Independent Review Charters, assessment criteria, data requirements, sponsor expectations, and operational workflows.
• Improve consistency across project builds by applying reusable standards, criteria-specific templates, and SDLC governance practices.
• Support Production Set-up leadership by identifying delivery risks, technical gaps, process inefficiencies, and opportunities for modernization.
• Help ensure applications support reliable, traceable, end-to-end data management from study setup through review, adjudication, reporting, and delivery.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior