Principal Clinical Data Standards Consultant

🕒 September 4

🌐 United Kingdom, Spain, +6 more countries – Remote

🇬🇧 United Kingdom – Remote 🇪🇸 Spain – Remote 🇭🇺 Hungary – Remote 🇧🇬 Bulgaria – Remote 🇷🇴 Romania – Remote 🇵🇹 Portugal – Remote 🇿🇦 South Africa – Remote 🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

💼 Consultant

👻 Ghost score 20%

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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 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. • Recommend and drive best practices to improve processes, products, and services. • Collaborate cross-functionally to define data collection strategies and standards for clinical trials. • Participate in standards governance activities and provide expert input on complex topics. • Lead or contribute to departmental initiatives, potentially acting as a project lead responsible for coordinating team members. • Support development of training materials and reference documentation on standards topics such as CDASH and Controlled Terminology. • Stay current with industry trends, regulatory changes, and emerging standards. • Provide mentorship and guidance to 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. • Legal right to work in the country where the role is based.

🏖️ 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