Principal Clinical Data Standards Consultant

This is a fully remote position, open to applicants in China.

📋 Description

• Offer expert-level functional expertise in at least one standards domain, aiding in the creation of standards content for both internal projects and those involving sponsors.

• Design, implement, and maintain ICON Data Collection standards libraries, ensuring compliance with CDISC, sponsor, and regulatory standards.

• Serve as a subject matter expert to facilitate standards implementation and guarantee compliance throughout clinical data management processes.

• Utilize a profound understanding of business challenges to propose and drive best practices, enhancing processes, products, and services for competitive advantage.

• Collaborate across various functions to establish data collection strategies and standards for clinical trials.

• Engage in standards governance activities, shaping decision-making and offering expert insights on complex issues.

• Lead or contribute to departmental projects, possibly taking on the role of project lead to coordinate team efforts.

• Assist in the creation of training materials and reference documentation on standards topics such as CDASH & Controlled Terminology.

• Remain informed on industry trends, regulatory updates, and emerging standards to ensure the ongoing enhancement of ICON practices.

• Provide mentorship and support to junior team members.

• Support a Chinese language version of the ICON Standards library and act as a subject matter expert for studies conducted in China.

⛳️ Requirements

• A Bachelor’s degree in a relevant field (e.g., Life Sciences, Computer Science, or a related area); advanced degrees are preferred.

• Approximately 8+ years of experience in clinical data management, with a strong focus on data standards.

• Advanced knowledge of CDISC standards (CDASH, SDTM, Controlled Terminology, etc.) and a solid understanding of regulatory requirements (FDA, EMA, etc.).

• Proven expertise with EDC build/design tools, such as Medidata Rave and/or Veeva Vault EDC/CDMS.

• Demonstrated capability to address complex issues, employing advanced analytical skills and sound judgment to devise innovative solutions.

• Strong leadership skills, including experience in leading initiatives or mentoring team members.

• Excellent interpersonal, communication, and influencing abilities, with the capacity to present, defend analyses, and achieve stakeholder alignment on intricate subjects.

• Ability to significantly influence operational, project, or departmental goals, ensuring the delivery of high-quality outcomes in line with business strategy.

🏝️ Benefits

• Competitive base salary and performance-related incentives.

• Health and wellbeing programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.