Clinical System Designer II
Job Requisition ID: JR141660
Employment Type: Full Time
Work Model: Office-Based with Flexible Work Options
Locations: Chennai, India | Bengaluru, India | Trivandrum, India
Experience Required: 3–6 Years
Job Overview
ICON plc, a global leader in healthcare intelligence and clinical research, is seeking a Clinical System Designer II to support the design, development, and optimization of clinical systems used in global clinical trials. This role is critical to ensuring efficient data capture, system usability, and regulatory compliance across clinical studies.
The Clinical System Designer II will collaborate with cross-functional stakeholders to translate clinical and operational requirements into scalable, compliant system designs that support high-quality clinical research outcomes.
Key Responsibilities
Clinical System Design & Implementation
Design, configure, and implement clinical trial systems, including CRF design and Medidata Rave EDC, to support accurate and efficient data collection.
Develop system specifications and workflows aligned with study protocols and operational requirements.
Stakeholder Collaboration
Partner with clinical operations, data management, biostatistics, and technology teams to gather requirements and translate them into functional system designs.
Act as a subject matter expert for clinical system functionality and usability.
System Validation & Compliance
Perform system testing, validation, and user acceptance testing (UAT) to ensure compliance with regulatory standards such as ICH-GCP and internal quality frameworks.
Support audit and inspection readiness by maintaining accurate system documentation.
User Support & Training
Provide training, guidance, and ongoing support to end users, addressing system-related queries and issues.
Troubleshoot and resolve system configuration or usability challenges in a timely manner.
Continuous Improvement
Contribute to continuous system enhancement initiatives by incorporating user feedback and industry best practices.
Support standardization and optimization of clinical system design processes across studies.
Required Qualifications & Experience
Bachelor’s degree in Computer Science, Information Technology, Life Sciences, or a related discipline.
Minimum 3 years of hands-on experience in clinical system design within a clinical research or CRO environment.
Demonstrated experience in CRF design and Medidata Rave EDC is mandatory.
Technical & Functional Skills
Strong understanding of clinical trial processes, data flow, and system lifecycle management.
Experience with clinical system implementation, testing, and validation activities.
Familiarity with regulatory guidelines governing clinical systems and electronic data capture.
Core Competencies
Strong analytical and problem-solving abilities with a high level of attention to detail.
Effective written and verbal communication skills.
Proven ability to collaborate effectively within cross-functional and global teams.
Ability to manage multiple priorities in a structured, deadline-driven environment.
Why Join ICON
ICON offers a collaborative, inclusive, and performance-driven work culture where professionals can grow their careers while contributing to meaningful clinical research. Employees benefit from competitive compensation, flexible work arrangements, and comprehensive benefits focused on well-being and work-life balance.
ICON is an equal opportunity employer committed to diversity, equity, and inclusion. All qualified applicants will be considered without regard to race, color, religion, gender, sexual orientation, national origin, disability, or veteran status.
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