Principal Data Standards Consultant

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

Principal Data Standard Consultant

As a Principal Clinical Data Standards Consultant at ICON Plc, you will:

Provide expert-level functional knowledge in at least one standards domain, contributing to the development of standards content both internally and for sponsor-facing projects.
Develop, implement, and maintain ICON standards libraries in compliance with CDISC, sponsor, and regulatory requirements.
Act as a subject matter expert to guide standards implementation and ensure compliance across clinical data management activities.
Apply deep understanding of business challenges to recommend and drive best practices, improving processes, products, and services to enhance competitive differentiation.
Collaborate cross-functionally to define data collection strategies and standards for clinical trials.
Participate in standards governance activities, influencing decision-making and providing expert input on complex topics.
Lead or contribute to departmental initiatives, potentially acting as a project lead with responsibility for coordinating team members.
Support the development of training materials and reference documentation across standards topics such as CDASH, SDTM, ADaM, Controlled Terminology, define-XML, and regulatory submissions.
Stay up to date with industry trends, regulatory changes, and emerging standards, ensuring continuous improvement of ICON practices.
Provide mentorship and guidance to more junior team members.

Requirements:

A Bachelor’s degree in a relevant discipline (e.g., Life Sciences, Computer Science, or similar); advanced degrees are advantageous.
Approximately 8+ years of experience in clinical data management, with significant expertise in data standards.
Advanced proficiency in CDISC standards and strong knowledge of regulatory requirements (FDA, EMA, etc.).
Proven experience with EDC build/design tools, such as Medidata Rave and/or Veeva Vault CDMS.
Demonstrated ability to solve complex problems, using advanced analytical thinking and sound judgment to develop innovative solutions.
Strong leadership capabilities, including experience leading initiatives or mentoring team members.
Excellent interpersonal, communication, and influencing skills, with the ability to present, defend analyses, and secure stakeholder alignment on complex topics.
Ability to significantly impact operational, project, or departmental objectives, ensuring delivery of high-quality outcomes aligned with business strategy.

If you are ready to make a meaningful impact in the field of clinical data standards and contribute to innovative, high-impact clinical projects, we encourage you to apply and join ICON’s growing team.

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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 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.

Are you a current ICON Employee? Please click here to apply

ICON plc

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Principal Clinical Data Standards Consultant