Principal Clinical Data Standards Consultant

Edit Job Requisition Additional Data: Principal Clinical Data Standards Consultant, Remote ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers. ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well. Job 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. •Develops and implements ICON end-to-end data standards libraries from data collection to analysis •Provides internal and external consulting services on topics related to CDISC standards compliance and standards implementation •Supports sponsors on the development, implementation, maintenance and governance of data standards content •Develops and delivers training for both internal teams and for external sponsors on CDISC standards related topics •Supports the development and maintenance of technologies used for the implementation of data standards •Participate in standards governance team meetings and provide standards input as assigned Functional Knowledge: • Expert functional knowledge level of at least one area of standards. Business Expertise: • Ability to apply expert knowledge of business challenges, and recommend best practices to improve products, processes or services to differentiate the business market. Develops standards content in area of expertise both internally and for sponsors. Provides guidance on standards implementation and compliance. • Travel (approximately 15%) domestic and/or international • Other responsibilities may be assigned as required Leadership: • Contribute to development of initiatives for the departmental possibly as project lead being responsible for other team members in a team lead role • May mentor more junior team members • 12-15 years experience • Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated Problem Solving: • Lead others to solve complex problems; use sophisticated analytical thought to exercise judgement and identify innovative solutions. Impact: • Significantly impact the achievement of operational, project, or department objectives; ensures quality standards are achieved; work is guided by business strategy. Interpersonal Skills: • Adapt style and use persuasion in delivering messages. Present and defend analysis and secure approval on complex matters. Benefits of Working in ICON: Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development. At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development. Benefits may include: 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 Benefits may vary depending on role and location. Visit our careers site to read more about the benefits ICON offers. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here . Are you a current ICON Employee? 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