Principal Clinical Data Standards Consultant

Principal Data Standard Consultant

UK

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 Data Collection 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 & Controlled Terminology.
• 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 (CDASH, SDTM, Controlled Terminology, etc.)  and strong knowledge of regulatory requirements (FDA, EMA, etc.).
• Proven experience with EDC build/design tools, such as Medidata Rave and/or Veeva Vault EDC/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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