Description
ICON is seeking a Principal Clinical Data Standards Consultant in China.
As a Principal Clinical Data Standards Consultant at ICON Plc, you will provide expert-level functional knowledge in at least one standards domain, contributing to the development of standards content both internally and for sponsor-facing projects.
Key responsibilities:
- Develop, implement, and maintain ICON Data Collection standards libraries in compliance with CDISC, sponsor, and regulatory requirements.
- Act as a subject matter expert to guide standards implementation and ensure compliance across clinical data management activities.
- Apply deep understanding of business challenges to recommend and drive best practices, improving processes, products, and services to enhance competitive differentiation.
- Collaborate cross-functionally to define data collection strategies and standards for clinical trials.
- Participate in standards governance activities, influencing decision-making and providing expert input on complex topics.
- Lead or contribute to departmental initiatives, potentially acting as a project lead with responsibility for coordinating team members.
- Support the development of training materials and reference documentation across standards topics such as CDASH & Controlled Terminology.
- Stay up to date with industry trends, regulatory changes, and emerging standards, ensuring continuous improvement of ICON practices.
- Provide mentorship and guidance to more junior team members.
- Support a Chinese language version of ICON Standards library and serve as SME for studies in China.
Requirements:
- A Bachelor’s degree in a relevant discipline (e.g., Life Sciences, Computer Science, or similar); 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, etc.) and strong knowledge of regulatory requirements (FDA, EMA, etc.).
- Proven experience with EDC build/design tools, such as Medidata Rave and/or Veeva Vault EDC/CDMS.
- Demonstrated ability to solve complex problems, using advanced analytical thinking and sound judgment to develop innovative solutions.
- Strong leadership capabilities, including experience leading initiatives or mentoring team members.
- Excellent interpersonal, communication, and influencing skills, with the ability to present, defend analyses, and secure stakeholder alignment on complex topics.
- Ability to significantly impact operational, project, or departmental objectives, ensuring delivery of high-quality outcomes aligned with business strategy.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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 wellbeing resources
- Learning and development opportunities through structured training and career pathways