Design the Digital Foundation 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 an experienced Clinical System Designer I to join our team in India. In this key role, you will be responsible for the detailed design and specification of clinical data capture systems. Your expertise will translate clinical trial protocols into efficient, user-friendly electronic Case Report Forms (eCRFs) and database components, ensuring data integrity, regulatory compliance, and study success.
Your Responsibilities: What You Will Be Doing
Core Design & Development:
- Interpret clinical trial protocols and customer requirements to design Clinical Data Management System (CDMS) components, including eCRFs, dynamic functionality, and edit checks.
- Utilize ICON and client-specific standards to make optimal design decisions.
- Develop custom CRF screens and specification documents using prototyping methodologies as needed.
- Assume responsibility for copying and modifying CRFs from standard libraries and previous studies.
Project Execution & Quality Control:
- Act as the first point of contact for design-related questions during the study build phase.
- Lead eCRF and specification review meetings with internal and external stakeholders.
- Perform quality control peer reviews of database specifications to ensure accuracy and adherence to requirements.
- Track project progress, identify potential issues affecting timelines or scope, and escalate effectively.
Business Expertise & Collaboration:
- Read and adhere to the study protocol, contract, and scope of work throughout the study lifecycle.
- Support the Clinical Systems Lead (CSL) in assessing impacts of post-production changes and compiling change management documentation.
- Collaborate with cross-functional teams, maintaining clear communication through meeting minutes, issues logs, and decision trackers.
- Recommend updates to standard libraries to continuously improve reusable components.
Your Profile: Qualifications & Skills
Experience & Education:
- 5+ years of relevant experience in clinical system design, eCRF design, and CDMS build within a CRO, pharmaceutical, or biotechnology setting.
- Strong functional knowledge of at least one major Clinical Data Management System (e.g., Medidata Rave, Oracle Clinical, Veeva) and CRF design tools.
- An equivalent combination of education, training, and experience will be considered.
Technical & Professional Skills:
- Proven ability to plan and design CDMS components directly from low to medium complexity clinical trial protocols.
- Excellent problem-solving skills with the ability to identify appropriate solutions for varied, non-routine issues.
- Strong written and oral communication skills, with effective cross-team collaboration abilities.
- Understanding of clinical data management processes, standards (CDISC), and regulatory guidelines.
- Willingness to undertake approximately 10% domestic/international travel.
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 data capture systems that drive global clinical research?
Apply now for the Clinical System Designer I position in India.
We encourage all interested candidates to apply. If you require a reasonable accommodation during the application process, please inform us.
