Job Title: Senior Clinical System Designer (EDC Developer)
Location: Bengaluru (Bangalore), India – Remote
Job Requisition ID: JR143004
Business Unit: ICON Strategic Solutions – Clinical Systems
Employment Type: Full-Time
Industry: Clinical Research | EDC Development | Clinical Data Management | CRO Technology
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking an experienced Senior Clinical System Designer (EDC Developer) to support advanced clinical trial system development initiatives. This remote opportunity is ideal for senior professionals with strong expertise in Electronic Data Capture (EDC) build, system configuration, clinical data workflows, and regulatory-compliant system design.
The role plays a critical part in enhancing trial design, improving operational efficiency, and ensuring clinical systems meet global regulatory and industry standards.
The Senior Clinical System Designer will lead the design, development, and optimization of clinical systems that support global clinical trials. This position requires deep technical expertise in EDC development, system integration, validation, and cross-functional collaboration within a matrixed CRO environment.
The successful candidate will drive innovation in clinical technology platforms while ensuring compliance with ICH-GCP and global regulatory frameworks.
Lead the end-to-end design and development of Electronic Data Capture (EDC) systems aligned with study protocols.
Configure CRFs, edit checks, validation rules, and workflow logic.
Oversee system integration and database build activities.
Ensure optimized usability, performance, and compliance across clinical systems.
Manage system testing, User Acceptance Testing (UAT), and validation processes.
Ensure systems comply with global regulatory standards and data integrity requirements.
Identify and resolve technical and functional issues prior to production deployment.
Provide technical and strategic guidance on new clinical technologies and system enhancements.
Drive innovation in clinical system design and automation.
Stay updated on industry trends in EDC, decentralized trials, and digital health technologies.
Lead continuous improvement initiatives within clinical systems operations.
Partner with Clinical Operations, Data Management, Biostatistics, and IT teams.
Translate protocol and operational requirements into technical system specifications.
Influence stakeholders and provide leadership in matrix environments.
Minimum 6–8+ years of experience in clinical system design and EDC development within the clinical research industry.
Proven hands-on expertise in:
EDC build and configuration
CRF design and edit check programming
Clinical database development
Experience working in global clinical trials across phases.
Strong exposure to system validation and regulatory compliance processes.
Experience leading or mentoring team members in system build activities is preferred.
Bachelor’s or Master’s degree in:
Computer Science
Biomedical Engineering
Information Technology
Life Sciences
Or related discipline
Advanced degree preferred.
Strong knowledge of:
Clinical data management systems
ICH-GCP guidelines
Clinical trial lifecycle processes
Expertise in EDC platforms (e.g., Medidata Rave or similar systems).
Experience in system integration and clinical technology platforms.
Strong analytical and problem-solving capabilities.
Excellent stakeholder management and communication skills.
Ability to drive change and innovation within complex global organizations.
Commitment to quality, compliance, and data integrity.
Remote role based in Bengaluru, India.
Exposure to global clinical development programs.
Opportunity to lead enterprise-level clinical system initiatives.
Collaborative and technology-driven CRO environment.
ICON provides a performance-focused and inclusive culture that supports professional development and work-life balance, including:
Competitive compensation packages.
Comprehensive health insurance plans.
Retirement planning benefits.
Global Employee Assistance Programme.
Life assurance coverage.
Flexible country-specific optional benefits.
ICON is committed to equal opportunity employment and fostering a diverse, inclusive workplace.
This role provides advancement pathways into:
Lead EDC Developer
Clinical Systems Architect
Clinical Technology Lead
Associate Director – Clinical Systems
Director – Clinical Data & Digital Platforms
Professionals in this role gain advanced expertise in enterprise EDC architecture, regulatory-compliant system design, digital trial enablement, and global clinical technology strategy.
If you have 6–8+ years of experience in EDC development and clinical system design within a CRO or pharmaceutical environment, this remote opportunity at ICON offers leadership exposure in global clinical technology transformation.
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