Principal Clinical Data Standards Consultant

About the role

ICON, a global healthcare intelligence and clinical research organisation, is hiring a Principal Clinical Data Standards Consultant in Shanghai. You will provide expert-level knowledge of clinical data standards, guide standards implementation across clinical data management activities and support the development of standards libraries in compliance with CDISC, sponsor and regulatory requirements.

Key responsibilities

• Develop, implement and maintain ICON Data Collection standards libraries in line with CDISC, sponsor and regulatory requirements.
• Act as a subject matter expert to guide standards implementation and ensure compliance across clinical data management activities.
• Collaborate cross-functionally to define data collection strategies and standards for clinical trials.
• Participate in standards governance activities and influence decision-making.
• Lead or contribute to departmental initiatives, potentially as a project lead coordinating team members.
• Support training materials and reference documentation on standards such as CDASH and Controlled Terminology.
• Stay up to date with industry trends, regulatory changes and emerging standards.
• Mentor junior team members and support a Chinese-language version of the ICON Standards library, serving as SME for studies in China.

Required profile

• Bachelor's degree in a relevant discipline (e.g. Life Sciences, Computer Science); 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) and strong knowledge of regulatory requirements (FDA, EMA).
• Experience leading initiatives or mentoring team members.
• Legal right to work in the country where the role is based.

Required skills

• EDC build/design tools such as Medidata Rave and/or Veeva Vault EDC/CDMS.
• Strong problem-solving, analytical thinking and leadership skills.
• Excellent communication and influencing skills, able to present and defend analyses and align stakeholders.

What we offer

• 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 learning and development opportunities.