Senior Software Engineer

Role Description

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.

Qualifications

• 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.

Requirements

• 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.
• 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.

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

Travel

Willingness to travel as required, approximately 15%, based on business, sponsor, audit, training, or project needs.