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 / BeneficiosCompetitive salaryAnnual leave entitlementsHealth insuranceRetirement planningGlobal Employee Assistance ProgrammeFlexible country-specific benefits ResponsabilidadesProvide expert knowledge in at least one standards domain and contribute to standards contentDevelop, implement,



and maintain ICON standards libraries aligned with CDISC and regulatory requirementsAct as SME to guide standards implementation and ensure regulatory/compliance across data managementCollaborate cross-functionally to define data collection strategies and standards for clinical trialsParticipate in standards governance and influence decision-making on complex topicsLead or contribute to departmental initiatives, potentially coordinating team membersSupport 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 practicesProvide mentorship and guidance to junior team members Requisitos principalesBachelor’s degree in Life Sciences, Computer Science, or a related field; advanced degrees advantageousApproximately 8+ years of experience in clinical data management with strong data standards expertiseAdvanced proficiency in CDISC standards and regulatory knowledge (FDA, EMA)Proven experience with EDC build/design tools (Medidata Rave and/or Veeva Vault CDMS)Strong analytical problem-solving abilities and sound judgment for innovative solutionsDemonstrated leadership capabilities, including mentoring or leading initiativesExcellent interpersonal, communication, and influencing skills for stakeholder alignmentAbility to impact operational, project, or departmental objectives and deliver high-quality outcomesleadershipinterpersonal skillscommunicationCDISC standardsMedidata RaveVeeva Vault CDMS

📌 Principal Clinical Data Standards Consultant - barcelona
🏢 Jobrapido
📍 Barcelona