Principal Clinical Data Standards Consultant (Barcelona)

Principal Clinical Data Standards Consultant (Barcelona)

16 sep
|
Icon Clinical
|
Barcelona

16 sep

Icon Clinical

Barcelona

Overview
As Principal Clinical Data Standards Consultant, you provide expert-level standards knowledge and shape ICON's standards content for internal and sponsor-facing projects. You will develop and maintain standards libraries compliant with CDISC and regulatory requirements, guiding data management activities. You collaborate across functions to define data collection strategies and participate in governance, driving best practices and continuous improvement. You mentor colleagues and contribute to training on CDASH, SDTM, ADaM, and related topics, shaping the standards program and ensuring high-quality outcomes.

Compensaciones / Ventajas
- Competitive salary
- Annual leave entitlements
- Health insurance
- Retirement planning
- Global Employee Assistance Programme
- Flexible country-specific benefits

Responsabilidades
- Provide expert knowledge in at least one standards domain and contribute to standards content
- Develop, implement, and maintain ICON standards libraries aligned with CDISC and regulatory requirements




- Act as SME to guide standards implementation and ensure regulatory/compliance across data management
- Collaborate cross-functionally to define data collection strategies and standards for clinical trials
- Participate in standards governance and influence decision-making on complex topics
- Lead or contribute to departmental initiatives, potentially coordinating team members
- Support development of training materials and reference documentation for standards topics (CDASH, SDTM, ADaM, define-XML)
- Stay updated with industry trends and regulatory changes to improve ICON practices
- Provide mentorship and guidance to junior team members

Requisitos principales
- Bachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degrees advantageous
- Approximately 8+ years of experience in clinical data management with strong data standards expertise
- Advanced proficiency in CDISC standards and regulatory knowledge (FDA, EMA

📌 Principal Clinical Data Standards Consultant (Barcelona)
🏢 Icon Clinical
📍 Barcelona

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