Senior Clinical EDC Systems Designer - Medidata Rave

job summary: A Top-Tier Global Pharma Leader is seeking a Systems Designer / Analyst III to lead hands-on EDC study design and specs creation. Based near Branchburg, NJ (or select company sites), this 1-year contract role offers the potential for FTE conversion and high-impact involvement in groundbreaking clinical trials across multiple therapeutic areas.

location: Somerville, New Jersey job type: Contract salary: $50.00 - 60.92 per hour work hours: 9 to 5 education: Bachelors

responsibilities:

• Hands-on design of clinical trial studies and creation of EDC specifications from scratch.
• Translate complex study requirements into paper specs and build system logic within EDC platforms.
• Coordinate cross-functionally with monitoring teams, clinical scientists, and statistical groups to ensure TA- and program-level consistency.
• Support Phase I studies (aesthetic/eyecare specialty) with flexibility to extend into oncology, neurology, and immunology.
• Ensure all clinical systems comply with CDISC standards (CDASH/SDTM), GCP, and ICH guidelines.

qualifications: Required:

• Must be a US Citizen or Green Card Holder (Visa sponsorship unavailable).
• 6-7+ years of relevant experience with a Bachelor’s degree (or Master’s/Ph.D. with 3-4+ years).
• Hands-on technical study build and EDC specification experience in Medidata Rave is required from Day 1.
• In-depth knowledge of CDASH (required) and SDTM standards with solid understanding of GCP.
• Must be local to/near Branchburg, NJ or select corporate hubs, or fully willing to relocate for a future hybrid FTE model (3 days onsite / 2 days WFH).

Preferred:

• Hands-on experience with Veeva EDC technology.
• Advanced degree (Master’s or Ph.D.).

skills: EDC (Electronic Data Capture), Medidata

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate’s education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

,

• Hands-on design of clinical trial studies and creation of EDC specifications from scratch.
• Translate complex study requirements into paper specs and build system logic within EDC platforms.
• Coordinate cross-functionally with monitoring teams, clinical scientists, and statistical groups to ensure TA- and program-level consistency.
• Support Phase I studies (aesthetic/eyecare specialty) with flexibility to extend into oncology, neurology, and immunology.
• Ensure all clinical systems comply with CDISC standards (CDASH/SDTM), GCP, and ICH guidelines.

EDC (Electronic Data Capture), Medidata