Clinical Systems Designer / EDC Study Builder

Job Summary

Responsibilities

• Design and deliver on-time clinical systems (EDC, IRT, ePRO) and system integrations, ensuring compliance with global data standards and study protocols.
• Establish and maintain design methodologies to optimize functionality, end-user experience, and end-to-end data flow.
• Drive consistency across Therapeutic Areas and clinical programs using project management tools to track progress and solve timeline risks.
• Ensure strict adherence to GCP, ICH guidelines, federal/local regulations, and internal quality standards.
• Coach and mentor design team members while leading cross-functional innovation and process improvement initiatives.

Qualifications

• Required: Bachelor's degree in MIS, Computer Science, Life Sciences, Business, or equivalent field.
• 7+ years of hands-on technical study build experience in Electronic Data Capture (EDC), with required expertise in Medidata RAVE.
• In-depth knowledge of CDASH standards and overall clinical trial processes.
• Proven ability to influence cross-functional teams without direct authority and mentor staff in a matrixed environment.

Preferred

• Master's degree.
• Experience with Veeva EDC technical study builds.
• Deep knowledge of SDTM standards.

Skills

• SDTM
• EDC (Electronic Data Capture)

Benefits

• Medical
• Prescription
• Dental
• Vision
• AD&D
• Life Insurance
• Short-term Disability
• 401K Plan