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Skills: CDISC Standards, CDASH, SDTM, Controlled Terminology, Clinical Data Management
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Full-time
bachelor degree, postgraduate degree
Competitive Base Salary, Performance Related Incentives, Medical Coverage, Dental Coverage, Vision Coverage, Retirement And Pension Plans
Posted 61d ago
~40 hrs/week
Remote in , Reading, United Kingdom
Responsibilities
The role involves developing and maintaining clinical data collection standards libraries in compliance with CDISC and regulatory requirements. The consultant will act as a subject matter expert to guide implementation, lead departmental initiatives, and provide mentorship to junior staff.
Requirements
Candidates need a Bachelor's degree in Life Sciences or Computer Science and at least 8 years of experience in clinical data management. Advanced proficiency in CDISC standards and experience with EDC tools like Medidata Rave or Veeva Vault are required.
Full job description
Principal Data Standards Consultant
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.
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 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.
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.
If you are ready to make a meaningful impact in the field of clinical data standards and contribute to innovative, high-impact clinical projects, we encourage you to apply and join ICON’s growing team.
#LI-JC3
#LI-Remote
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? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
Medical DeviceTherapeuticsGovernment and Public Health SolutionsClinical Research ServicesCommercialisation and OutcomesOncologyValue Based HealthcareClinical TrialsPatient RecruitmentInnovation
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