Systems Designer / Analyst II

This position is located in Branchburg, NJ, with preference given to candidates in New Jersey or near a client office. Remote candidates with strong experience will also be considered.

About the role

Lead the design, build, and delivery of clinical trial systems, including EDC, IRT, and ePRO. Develop and implement common data standards across clinical studies. Perform hands-on technical study build in Medidata Rave while ensuring compliance with protocol and data standards. Ensure consistency of clinical system design across therapeutic areas and programs. Manage system integrations and coordinate required study updates. Track study build progress and ensure timely delivery using project management methodologies. Ensure compliance with GCP, ICH Guidelines, SOPs, and applicable regulatory requirements. Lead process improvement and innovation initiatives within Clinical Data Strategy.

Requirements

• Bachelor's degree in Business, Management Information Systems, Computer Science, Life Sciences, or a related field
• Master's degree preferred
• 7+ years of hands-on technical study build experience in Medidata Rave EDC
• Clinical Electronic Data Capture (EDC) system design and configuration
• CDASH standards
• SDTM standards
• Clinical trial system implementation (EDC, IRT, ePRO)
• Clinical data standards development
• Clinical trial process expertise
• GCP, ICH Guidelines, and clinical regulatory compliance

Preferred Skills

• Veeva EDC technical study build experience
• Clinical system integration experience
• Clinical Data Strategy process improvement and standardization
• Cross-study/program clinical system design expertise

Pay

$42–$46/hour (W2)

Schedule

1-year contract with potential extension for a second year.