# Principal Clinical Data Standards Consultant

**Company**: ICON
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/China-Shanghai/Principal-Clinical-Data-Standards-Consultant_JR154704?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_201eb10d-fb8

## 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

## Skills

### Required
- CDISC standards
- clinical data management
- data standards
- EDC build/design tools
- Medidata Rave
- Veeva Vault EDC/CDMS
- Chinese

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/China-Shanghai/Principal-Clinical-Data-Standards-Consultant_JR154704?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)