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About the Role

The Senior Engineer, Clinical Trial Technology and Medical Imaging Applications is responsible for designing, developing, configuring, validating, and supporting project-specific analysis applications used in clinical trials. This role requires expertise in clinical trial technology, medical imaging, software engineering, and regulated SDLC practices to deliver reliable technology solutions.

Responsibilities

• Design, develop, configure, enhance, and maintain project-specific applications supporting clinical trial endpoints, imaging review, and operational workflows.
• Translate complex clinical, scientific, and operational requirements into technical specifications and application logic.
• Develop solutions for medical imaging, centralized review, endpoint assessment, and clinical data capture.
• Partner with cross-functional teams to ensure applications meet study needs and customer expectations.
• Support application modernization, workflow automation, and reduction of technical debt.
• Develop and support systems for Blinded Independent Central Review, eligibility review, and adjudication workflows.
• Review and interpret clinical trial protocols and imaging manuals to ensure application design aligns with study requirements.
• Support workflows for image transfer, de-identification, reconciliation, and archival.
• Design technology solutions for consistent end-to-end data flow across various systems.
• Ensure alignment between imaging data, clinical data, and reporting outputs.
• Identify and mitigate data integrity risks and workflow gaps.
• Partner with Data Management to improve data mapping and reconciliation processes.
• Lead and support all phases of the software development lifecycle, including requirements, design, development, testing, validation, and deployment.
• Maintain traceability between requirements, design, test scripts, and validation evidence.
• Develop and maintain SDLC governance materials, technical documentation, and training materials.
• Support risk assessments, impact assessments, and regulated change control.
• Ensure systems align with applicable quality and regulatory expectations (GxP, 21 CFR Part 11, etc.).
• Lead process improvement initiatives focused on quality, standardization, and operational efficiency.
• Identify workflow bottlenecks and technical debt.
• Develop reusable development standards, templates, and testing frameworks.
• Support portfolio-level governance, prioritization, and delivery tracking.
• Provide technical input for RFIs, sponsor assessments, and client audits.
• Serve as a senior technical advisor to various teams.
• Communicate complex technical concepts clearly to diverse stakeholders.
• Mentor engineers and analysts, and promote knowledge sharing.

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.
• 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.
• Experience reviewing and translating clinical trial protocols, imaging manuals, and Independent Review Charters into application functionality.
• Experience supporting systems or applications used for medical imaging, centralized review, and clinical data capture.
• 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 deliver high-quality technical solutions with limited oversight.
• Working knowledge of imaging and endpoint assessment criteria across therapeutic areas is strongly preferred.
• 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 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, and study configuration standards.
• Experience leading modernization initiatives, workflow automation, and technical debt remediation.
• Experience mentoring technical team members and building organizational knowledge management practices.
• Deep understanding of clinical trial operations, medical imaging workflows, and regulated clinical technology delivery.
• Ability to translate complex requirements into practical application solutions.
• Strong independent decision-making, prioritization, analytical thinking, and problem-solving skills.
• Strong quality mindset with focus on data integrity, traceability, compliance, and customer satisfaction.
• Ability to influence cross-functional stakeholders and communicate clearly.
• Commitment to process improvement, standardization, and knowledge sharing.
• Willingness to travel as required, approximately 15%.

Skills

• Python
• Java
• SQL
• REST APIs
• JavaScript
• Web technologies
• Database design
• Application architecture
• Workflow automation
• Source control
• CI/CD
• Release management
• BPM
• Workflow orchestration
• Camunda BPM
• EDC
• eCRF design
• Clinical databases
• Clinical data review systems
• CTMS
• Study management tools
• Operational reporting
• Data exports
• Clinical data integrations
• DICOM standards
• Image transfer workflows
• Imaging archives
• Imaging viewers
• Image QC
• Reader platforms
• Annotation and measurement tools
• Central review platforms
• AI-enabled imaging solutions
• Production Set-up
• Project application build environments
• EDC/eCRF/database integrations
• Criteria-specific application standards
• Sponsor-specific study configurations
• 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
• GDPR
• Data mapping
• Data reconciliation
• Edit checks
• Endpoint data consistency
• Operational dashboards
• Sponsor reporting
• Downstream data delivery standards
• RECIST 1.1
• iRECIST
• irRECIST
• mRECIST
• Lugano
• Cheson
• LYRIC
• RANO
• PCWG3
• Volumetric assessments
• Cardiac assessments
• MSK imaging workflows
• GI imaging workflows
• Neuro imaging workflows
• AI-assisted imaging analysis
• Quantitative imaging
• Segmentation
• Volumetric analysis
• Radiomics
• Machine learning enabled imaging workflows

Location

• Remote

Work Type

• Full-time

Experience Level

• Senior
• 8+ years

Education Level

• Bachelor's degree
• Advanced degree 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

About the Company

• 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.

Equal Opportunity

• ICON is an equal opportunity employer.
• We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.