Systems Designer / Analyst III

Job Summary

Responsibilities

Conduct hands-on design of clinical studies and author detailed EDC specifications from scratch.

Develop common data standards and build EDC systems ensuring strict compliance with protocols, GCP, and ICH guidelines.

Lead cross-functional collaboration across study teams, monitoring groups, clinical scientists, and statistical teams.

Ensure on-time delivery of clinical systems (EDC, IRT, ePRO), system integrations, and protocol changes.

Establish system design methodologies that optimize functionality, end-user experience, and clinical data flow.

Actively participate in study reviews, navigate team dynamics, and close out clinical trials smoothly.

Qualifications

• Required: Bachelor's degree with 6-7+ years of experience, or Master's/Ph.D. with 3-4+ years of relevant experience.
• 7+ years of hands-on technical study build experience in Medidata Rave (Day 1 requirement).
• Proven experience building EDC specifications from scratch and hands-on CDASH/SDTM knowledge.
• Strong cross-functional coordination, project management, and collaboration skills.
• Willingness to work hybrid (3 days onsite / 2 days WFH) upon potential FTE conversion.
• Preferred Phase I experience (specifically Aesthetic/Eyecare specialties) or broad therapeutic background (Oncology, Neurology, Immunology).
• Prior experience with Veeva EDC technology.

Skills

• EDC (Electronic Data Capture)
• Medidata

Benefits

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