Senior Clinical Validation Analyst - India
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
Sr. Clinical Validation Analyst to support the development, validation, and testing of EDC systems within clinical trials. The ideal candidate will have strong expertise in Medidata Rave, demonstrated experience in peer review and UAT coordination, and a deep understanding of clinical data workflows.
Key Responsibilities
EDC Development & Validation
- Develop, validate, and maintain study builds within Medidata Rave.
- Validate edit checks, custom functions, and other programmed components.
- Perform endtoend testing of clinical study components to ensure system accuracy and compliance.
Quality Oversight & Peer Review
- Conduct detailed peer review of edit checks, custom functions, forms, and datasets.
- Ensure alignment with study requirements, protocol specifications, and data management plans.
UAT Management
- Facilitate and coordinate User Acceptance Testing (UAT) with crossfunctional teams.
- Prepare UAT documentation, track findings, and ensure all issues are resolved before golive.
- Support study teams and end users during UAT cycles.
Required Qualifications
- Minimum 5+ years of handson EDC development experience within biotechnology or pharmaceutical organizations.
- Advanced experience with Medidata Rave, including testing of multiple study components.
- Bachelor's degree in Life Sciences, Computer Science, or a related field.
Preferred Skills
- Strong understanding of clinical data management processes.
- Ability to work independently and manage multiple projects simultaneously.
- Excellent communication, documentation, and problemsolving skills.
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here
Interested in the role, but unsure if you meet all of the requirements We would encourage you to apply regardless there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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