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ICON plc

Senior Clinical Validation Analyst

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Job Description

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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

    Visit our 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.

    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.

    Are you a current ICON Employee Please click to apply

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    About Company

    Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.We offer a full range of consulting, development and commercialisation services from a global network of offices in 37 countries. We focus our innovation on the factors that are critical to our clients &#8211&#x3B; reducing time to market, reducing cost, and increasing quality &#8211&#x3B; and our global team of experts has extensive experience in a broad range of therapeutic areas.

    Job ID: 145003607