Systems Designer / Analyst II

• 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.

• 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

The Fountain Group is currently seeking a Systems Designer / Analyst II for a prominent client of ours. This position is located in Branchburg, NJ . Details for the position are as follows