Design the Digital Backbone of Clinical Trials
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are seeking a skilled Clinical Systems Designer II to join our team in Chennai or Bengaluru. In this crucial role, you will be the architect of clinical data capture systems, designing and optimizing electronic Case Report Forms (eCRFs) and EDC builds that ensure the integrity, quality, and efficiency of global clinical trials. Your work will directly support the advancement of new therapies by creating robust, user-friendly, and compliant data collection tools.
Your Responsibilities: What You Will Be Doing
- System Design & Build: Design, build, and implement clinical data capture systems, with a primary focus on eCRF design and development in Medidata Rave and other leading EDC platforms.
- Requirement Translation: Collaborate with Clinical Data Managers, Biostatisticians, and Clinical Operations to gather and translate complex study protocols and data collection requirements into clear, logical system specifications.
- Testing & Validation: Conduct thorough system testing, User Acceptance Testing (UAT), and validation to ensure the system meets user needs and complies with ICH-GCP, 21 CFR Part 11, and sponsor-specific requirements.
- User Support & Training: Provide expert support and training to end-users (e.g., site coordinators, data managers), addressing functional issues and ensuring smooth system adoption.
- Continuous Improvement: Participate in the ongoing enhancement of clinical systems and processes by incorporating user feedback and implementing industry best practices.
Your Profile: Qualifications & Skills
Education & Experience:
- A Bachelor's degree in Computer Science, Information Technology, Life Sciences, or a related field.
- Minimum of 3 years of direct, hands-on experience in Clinical System Design, specifically with eCRF design and Medidata Rave EDC.
- Experience in system design and implementation within a CRO, pharmaceutical, or biotechnology clinical research environment.
Technical Skills & Competencies:
- Strong understanding of clinical trial processes, data management workflows, and regulatory standards.
- Proficiency in EDC build activities, including form design, edit check programming, and dashboard configuration.
- Excellent problem-solving skills and meticulous attention to detail in system functionality, data flow, and usability.
- Effective communication and collaboration skills, with a proven ability to work successfully in cross-functional, global teams.
Why Join ICON?
Our success depends on the quality of our people. That’s why we prioritize building a diverse culture that rewards high performance and nurtures talent.
We Offer a Competitive Benefits Package Focused on Well-Being:
- Generous Annual Leave entitlements.
- Comprehensive Health Insurance options for you and your family.
- Competitive Retirement Planning offerings to secure your future.
- Global Employee Assistance Programme providing 24/7 confidential support.
- Life Assurance coverage.
- Flexible, Country-Specific Benefits which may include wellness programs, subsidized travel, and more.
Our Commitment to You:
At ICON, inclusion and belonging are fundamental to our culture and values. We are dedicated to providing an inclusive and accessible environment and are proud to be an equal opportunity employer.
Ready to architect the systems that capture the data driving medical breakthroughs?
Apply now for the Clinical Systems Designer II position in Chennai or Bengaluru.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
