Job Title: Clinical System Designer I (CSD I) – EDC & CRF Design
Locations: Bengaluru, Bangalore, Chennai, Trivandrum, India (Office-Based)
Job Requisition ID: JR141660
Business Unit: ICON Full Service & Corporate Support – Clinical Systems
Employment Type: Full-Time
Industry: Clinical Research | Clinical Data Management | EDC Systems | CRO
ICON plc, a global leader in healthcare intelligence and clinical research, is hiring a Clinical System Designer I (CSD I) to support clinical trial system development across its India offices. This office-based opportunity is ideal for professionals with experience in Electronic Data Capture (EDC), CRF design, Medidata Rave build, and clinical system validation.
This role contributes directly to optimizing clinical trial data collection systems, ensuring compliance with regulatory standards and improving overall study efficiency.
As a Clinical System Designer I, you will be responsible for designing, building, testing, and maintaining clinical systems that support global clinical trials. You will collaborate with cross-functional teams to translate protocol requirements into efficient, compliant EDC solutions.
The position requires hands-on expertise in CRF design and Medidata Rave configuration, along with a strong understanding of clinical trial workflows and regulatory compliance standards.
Design and configure Electronic Data Capture (EDC) systems, including CRF design in Medidata Rave.
Translate clinical trial protocols into functional system specifications.
Develop edit checks, validation rules, and data workflows aligned with study requirements.
Optimize system functionality to improve data accuracy and usability.
Conduct User Acceptance Testing (UAT) and system validation activities.
Ensure systems comply with regulatory requirements including ICH-GCP and applicable guidelines.
Identify and resolve system issues during development and deployment.
Work closely with Clinical Data Management, Biostatistics, Clinical Operations, and IT teams.
Gather business and study requirements to ensure accurate system configuration.
Provide technical support and guidance to study teams.
Provide user training and ongoing system support.
Participate in process improvements and system optimization initiatives.
Incorporate industry best practices and user feedback into system enhancements.
Minimum 3+ years of experience in Clinical System Design.
Proven hands-on experience in:
CRF Design
Medidata Rave build and configuration
Experience working within a clinical research or CRO environment.
Familiarity with clinical data management processes from study start-up to database lock.
Experience in system validation and regulatory compliance within clinical trials.
Bachelor’s degree in:
Computer Science
Information Technology
Life Sciences
Or related field
Advanced certifications in clinical data management or EDC systems are considered an advantage.
Strong understanding of clinical trial processes and regulatory requirements.
Knowledge of ICH-GCP and global clinical compliance standards.
Excellent analytical and problem-solving skills.
High attention to detail in system design and validation.
Effective communication and cross-functional collaboration skills.
Ability to manage multiple projects and deadlines in a structured environment.
Office-based role across Bengaluru, Bangalore, Chennai, or Trivandrum.
Opportunity to work on global clinical trials across therapeutic areas.
Exposure to enterprise-level EDC platforms and clinical technologies.
Collaborative, performance-driven CRO environment.
ICON fosters a culture focused on innovation, inclusion, and professional growth. Employees benefit from:
Competitive salary and performance-based rewards.
Comprehensive health insurance plans.
Retirement planning benefits.
Global Employee Assistance Program.
Life assurance coverage.
Flexible, country-specific benefits supporting work-life balance.
ICON is committed to diversity, inclusion, and equal opportunity employment.
This role provides progression pathways into:
Senior Clinical System Designer
EDC Lead / Study Build Lead
Clinical Data Management Lead
Clinical Systems Manager
Professionals gain deep expertise in EDC configuration, CRF optimization, regulatory-compliant system design, and global clinical trial technology platforms.
If you have 3+ years of experience in CRF design and Medidata Rave within a clinical research environment, this opportunity with ICON offers career advancement in global clinical systems and data management.a
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