Senior Clinical EDC Systems Designer - Medidata Rave

Randstad USA; Somerville (NJ); Hybrid; USD 69,000 - 84,000; Full time

Job summary

Randstad USA 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 potential for FTE conversion and high-impact involvement in groundbreaking clinical trials across multiple therapeutic areas.

Responsibilities include hands-on EDC design, translating requirements into specs, coordinating cross-functionally, and ensuring CDISC/GCP compliance.

Qualifications

• US Citizenship or Green Card required; visa sponsorship unavailable.
• 6–7+ years of relevant experience with a Bachelor's degree (or 3–4+ years with MS/PhD).
• Hands-on EDC design and specification experience in Medidata Rave from Day 1.
• In-depth knowledge of CDASH and SDTM with solid GCP understanding.
• Willing to relocate for a hybrid model (3 days onsite / 2 days WFH) near Branchburg, NJ.

Responsibilities

• Hands-on design of clinical trial studies and creation of EDC specifications.
• 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 with flexibility to extend into oncology, neurology, and immunology.
• Ensure all clinical systems comply with CDISC standards (CDASH/SDTM), GCP, and ICH guidelines.

Skills

EDC

Medidata

Education

Bachelor's degree

Tools

Medidata Rave

Job description

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 [e-mail].

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.