Principal Clinical Data Standards Consultant

Experteer 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 / Beneficios * 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 Responsabilidades * 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) * Proven experience with EDC build/design tools (Medidata Rave and/or Veeva Vault CDMS) * Strong analytical problem-solving abilities and sound judgment for innovative solutions * Demonstrated leadership capabilities, including mentoring or leading initiatives * Excellent interpersonal, communication, and influencing skills for stakeholder alignment * Ability to impact operational, project, or departmental objectives and deliver high-quality outcomes Requisitos principales * Competitive salary * Annual leave entitlements * Health insurance * Retirement planning * Global Employee Assistance Programme * Flexible country-specific benefits

Compensaciones / Beneficios * 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 Responsabilidades * 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) * Proven experience with EDC build/design tools (Medidata Rave and/or Veeva Vault CDMS) * Strong analytical problem-solving abilities and sound judgment for innovative solutions * Demonstrated leadership capabilities, including mentoring or leading initiatives * Excellent interpersonal, communication, and influencing skills for stakeholder alignment * Ability to impact operational, project, or departmental objectives and deliver high-quality outcomes Requisitos principales * Competitive salary * Annual leave entitlements * Health insurance * Retirement planning * Global Employee Assistance Programme * Flexible country-specific benefits