Principal Clinical Data Standards Consultant

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

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 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