Principal Clinical Data Standards Consultant

Icon Clinical Plc; Madrid; Presencial; EUR 90.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Learning and development opportunities

Employee assistance programmes

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organisation seeking a Principal Data Standards Consultant to advance data collection standards and CDISC governance. You will lead expert activities, shape standard libraries, and collaborate across clinical teams to ensure compliant data practices in trials.

With 8+ years in clinical data management and deep CDISC proficiency, you will mentor staff, influence project directions, and drive process improvements in a fast-paced,

Formación

• Bachelor’s degree in Life Sciences, Computer Science, or similar; advanced degrees are advantageous.
• 8+ years of experience in clinical data management with significant expertise in data standards.
• Advanced proficiency in CDISC standards (CDASH, SDTM, Controlled Terminology) and strong regulatory knowledge (FDA, EMA).

Responsabilidades

• Provide expert-level functional knowledge in at least one standards domain and contribute to standards content.
• Develop, implement, and maintain ICON Data Collection standards libraries per CDISC and regulatory requirements.
• Act as a subject matter expert to guide standards implementation across clinical data management activities.
• Collaborate cross-functionally to define data collection strategies and standards for clinical trials.
• Lead or contribute to departmental initiatives and mentor junior team members.
• Stay updated with industry trends and regulatory changes to improve ICON practices.

Conocimientos

CDISC standards

Regulatory knowledge

Data standards

Leadership

Mentoring

EDC tools

Medidata Rave

Veeva Vault

Educación

Bachelor’s degree in Life Sciences

Herramientas

Medidata Rave

Veeva Vault

EDC/CDMS

Descripción del empleo

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

Responsibilities

• 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.

Rewards & 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

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.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Location

Location: UK, Reading; Spain, Barcelona; Hungary, Budapest; Bulgaria, Sofia; Romania, Bucharest; Portugal, Lisbon; South Africa, Johannesburg; Ireland, Dublin

Type: Full time

Principal Clinical Data Standards Consultant • Madrid, Spain