Senior CDISC Data Standards Lead – Clinical Trials

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

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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

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,