ICON plc
Principal Clinical Data Standards Consultant
USARemotePosted 1 month ago€20 – €40
Full TimeSeniorRemoteUS
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Job Description
Principal Data Standards ConsultantICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excelle
Key Highlights
- 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.
- Develop, implement, and maintain ICON 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.
Qualifications
Required Qualifications
- 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 and strong knowledge of regulatory requirements (FDA, EMA, etc.).
- Proven experience with EDC build/design tools, such as Medidata Rave and/or Veeva Vault 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.
About the Company
ICON plc
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Job Details
Employment Type
Full Time
Experience Level
Senior
Salary Range
€20 – €40
Location
USA
Work Mode
Remote
Posted
1 month ago
Country
US