Senior Software Engineer – Medical Imaging

🔥 19 horas atrás

🗽 New York, Pennsylvania – Remoto

🗽 New York – Remote 🔔 Pennsylvania – Remote

⏰ Tempo Integral

🟠 Sênior

🧑‍💻 Engenheiro Full-stack

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ICON plc

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1990

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A ICON plc é uma provedora global de serviços clínicos, de consultoria e comerciais que atendem a diversos setores das indústrias de saúde e farmacêutica. A empresa oferece uma ampla gama de soluções clínicas, incluindo ensaios clínicos descentralizados, soluções de segurança cardíaca, laboratórios clínicos de fases iniciais e imagem médica. A ICON também fornece soluções de tecnologia que apoiam o desenvolvimento de medicamentos desde as fases iniciais até o pós-comercialização. Sua expertise terapêutica abrange cardiovascular, oncologia, medicina interna e mais, com forte foco em terapias transformadoras, como terapias celulares e gênicas e biossimilares. Reconhecida como uma das principais CROs (Contract Research Organisations), a ICON oferece regularmente thought leadership e contribui para publicações e eventos do setor. Seus serviços são personalizados para otimizar ensaios clínicos, fornecer inteligência regulatória e gerar evidências do mundo real por meio de análise de dados robusta e soluções centradas no paciente.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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