Clinical Systems Designer / EDC Study Builder

job summary: Join a top-tier global pharmaceutical leader as a Systems Designer / Analyst II, driving innovation in clinical trial data systems. This role offers flexible location options, with a preference for Branchburg, NJ, proximity to a company office, or full remote flexibility for candidates with strong Medidata Rave expertise.

location: Somerville, New Jersey job type: Contract salary: $35.00 - 44.53 per hour work hours: 9 to 5 education: Bachelors

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.

#LI-ST1

skills: SDTM, EDC (Electronic Data Capture)

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.

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• 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.

SDTM, EDC (Electronic Data Capture)