Principal Clinical Data Standards Consultant

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• 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. • Supporting a Chinese language version of ICON Standards library and serve as SME for studies in China.

🎯 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.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways