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 and develop 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 • Guide standards implementation and ensure compliance across clinical data management activities • Recommend and drive best practices to improve processes, products, and services • Define data collection strategies and standards for clinical trials with cross-functional teams • Participate in standards governance activities and provide expert input on complex topics • Lead or contribute to departmental initiatives, potentially serving as project lead and coordinating team members • Support development of training materials and reference documentation on CDASH and Controlled Terminology • Monitor industry trends, regulatory changes, and emerging standards • Mentor and guide junior team members • Develop and implement end-to-end data standards libraries from data collection to analysis • Provide internal and external consulting on CDISC standards compliance and implementation • Support sponsors with development, implementation, maintenance, and governance of data standards content • Develop and deliver training for internal teams and external sponsors • Support development and maintenance of technologies used to implement data standards • Participate in standards governance team meetings and provide standards input • Lead others in solving complex problems and identify innovative solutions • Present and defend analyses and secure approval on complex matters • Travel approximately 15% domestically and/or internationally

🎯 Requirements

• Expert functional knowledge in at least one standards area • Ability to apply expert knowledge of business challenges and recommend best practices • Experience developing standards content internally and for sponsors • Ability to provide guidance on standards implementation and compliance • 12–15 years of experience • Equivalent combination of education, training, and relevant experience may be considered in place of the stated education and experience • Ability to lead others in solving complex problems using sophisticated analytical thought • Ability to exercise judgment and identify innovative solutions • Ability to significantly impact operational, project, or departmental objectives • Ability to ensure quality standards are achieved • Ability to work guided by business strategy • Ability to adapt communication style and use persuasion • Ability to present and defend analysis and secure approval on complex matters • Willingness to travel approximately 15% domestically and/or internationally • Legal right to work in the country where the role is based

🏖️ Benefits

• Continuous learning culture and professional development opportunities • Comprehensive and competitive total reward package • Excellent base pay • Variable pay and recognition programs • 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 • Supportive policies and wellbeing initiatives • Reasonable accommodations during the recruitment process