Senior EDC Designer (Medidata Rave) – Clinical Trials Lead

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

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.