Senior Clinical System Designer (EDC Developer)
Location: India – Bangalore (Remote)
Employment Type: Full-Time
Experience Required: 6–10 Years
Job Requisition ID: JR143004
Industry: Clinical Research | Clinical Data Management | EDC Systems | Health Technology
About ICON plc
ICON plc is a globally recognized healthcare intelligence and clinical research organization supporting the development of innovative therapies worldwide. With a strong focus on quality, compliance, and technological innovation, ICON partners with biopharmaceutical, biotechnology, and medical device companies to accelerate clinical development while maintaining the highest regulatory and operational standards.
Role Overview
The Senior Clinical System Designer (EDC Developer) plays a critical role in the design, development, and optimization of electronic data capture (EDC) and clinical trial systems. This position supports global clinical studies by ensuring system configurations align with study protocols, regulatory requirements, and operational efficiency. The role involves close collaboration with cross-functional stakeholders to drive system innovation and enhance trial execution.
Key Responsibilities
Lead the design, configuration, and implementation of clinical systems, including EDC platforms, in alignment with study protocols and operational requirements
Translate protocol and clinical data management specifications into efficient, compliant system designs
Collaborate with clinical operations, data management, biostatistics, and IT teams to identify opportunities for system enhancements and process improvements
Oversee system integrations, user acceptance testing (UAT), and validation activities to ensure system performance and compliance
Provide subject matter expertise on clinical system architecture, industry best practices, and emerging clinical technologies
Support risk-based approaches to system design and data quality management
Ensure all system-related activities comply with ICH-GCP, regulatory guidelines, and internal SOPs
Contribute to continuous improvement initiatives by staying current with advancements in clinical trial technology
Required Qualifications
Bachelor’s or Master’s degree in Computer Science, Biomedical Engineering, Life Sciences, or a related discipline
6–10 years of hands-on experience in clinical systems design, EDC development, or clinical data management within the CRO, pharmaceutical, or biotechnology industry
Strong expertise in EDC platforms and clinical trial system configuration and validation
Proven experience working in cross-functional and matrixed global teams
Solid understanding of clinical trial processes, clinical data standards, and regulatory compliance requirements
Strong analytical, problem-solving, and data interpretation skills
Excellent verbal and written communication skills with the ability to influence stakeholders
Preferred Skills
Experience with multiple EDC systems and clinical trial technologies
Familiarity with CDISC standards (SDTM, CDASH)
Experience supporting global, multi-region clinical trials
Knowledge of risk-based data management and system-driven monitoring approaches
Work Model
This is a remote-based role with operational alignment to Bangalore, India. Flexible work arrangements support collaboration across global study teams.
Why Join ICON
ICON offers a performance-driven and inclusive work environment where innovation, collaboration, and professional growth are prioritized. Employees benefit from competitive compensation, comprehensive health and wellness programs, global career opportunities, and a strong commitment to work–life balance.
Diversity and Equal Opportunity
ICON is an equal opportunity employer committed to creating a diverse and inclusive workplace. All qualified applicants are considered without regard to race, religion, gender, disability, or any other protected characteristic.
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