Clinical Data Systems Lead

Job Summary

Leading the design and delivery of clinical trial systems, the full-time Clinical Data Systems Lead will manage EDC, IRT, and ePRO builds, ensuring compliance and consistency across studies, while working remotely or onsite in New Jersey.

Key responsibilities

• Lead the design, build, and delivery of clinical trial systems including EDC, IRT, and ePRO
• Develop and implement common data standards across clinical studies
• Track study build progress and ensure timely delivery using project management methodologies

Required qualifications

• Bachelor's degree in Business, Management Information Systems, Computer Science, Life Sciences, or a related field
• 7+ years of hands-on technical study build experience in Medidata Rave EDC
• Expertise in clinical trial system implementation (EDC, IRT, ePRO)
• Knowledge of CDASH and SDTM standards
• Understanding of GCP, ICH Guidelines, and clinical regulatory compliance