Clinical Data Manager - Medidata Rave Specialist

Randstad USA

Somerville (NJ)

Hybrid

USD 69,000 - 84,000

Full time

12 days ago
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Benefits offered by this job

Medical
Prescription
Dental
Vision
AD&D
Life insurance
Short-term disability
401K plan

Job summary

Randstad USA is seeking a Systems Designer/Analyst III with deep Medidata Rave expertise to lead hands-on Electronic Data Capture (EDC) design for multi-phase clinical trials.

This long-term contract role offers high-visibility collaboration across studies from Phase I to IV and potential for full-time conversion, with on-site or hybrid work in NJ or IL. You will translate protocol requirements into functional database designs, drive study design reviews, and ensure GCP/ICH/SDTM compliance.

Qualifications

  • Hands-on Medidata Rave experience with proven ability to build EDC specifications from Day 1.
  • Minimum 6–7+ years of experience with a Bachelor’s degree, or 3–4+ years with a Master’s/Ph.D.
  • Strong working knowledge of Good Clinical Practice (GCP), ICH guidelines, and SDTM standards.
  • Excellent cross-functional project management, communication, and team coordination skills.
  • Willingness to work onsite/hybrid in NJ or IL, or relocate if offered permanent FTE conversion.

Responsibilities

  • Perform hands-on design of clinical studies and draft detailed EDC specifications from scratch.
  • Translate complex clinical protocol requirements into functional database designs and architecture.
  • Coordinate cross-functionally with data management, clinical scientists, statistical teams, and field monitors.
  • Lead study design reviews, navigate multidisciplinary team dynamics, and manage study close-out activities.
  • Ensure all clinical system deliverables comply with GCP, ICH guidelines, and SDTM controlled terminology.

Skills

EDC
Medidata

Education

Bachelor's degree

Job description

Job Summary

Drive the future of clinical trials with a premier global biopharmaceutical leader based in Branchburg, NJ. We are seeking a Systems Designer / Analyst III with deep Medidata Rave expertise to lead hands‑on Electronic Data Capture (EDC) design. This long‑term contract role offers high‑visibility collaboration across Phase I through Phase IV studies and strong potential for full‑time conversion.

Location & Employment Details

Location: Somerville, New Jersey

Job type: Contract

Salary: $50.00 - 60.92 per hour

Work hours: 9 to 5

Education: Bachelors

Responsibilities
  • Perform hands‑on design of clinical studies and draft detailed EDC specifications from scratch.
  • Translate complex clinical protocol requirements into functional database designs and architecture.
  • Coordinate cross‑functionally with data management, clinical scientists, statistical teams, and field monitors.
  • Lead study design reviews, navigate multidisciplinary team dynamics, and manage study close‑out activities.
  • Ensure all clinical system deliverables comply with GCP, ICH guidelines, and SDTM controlled terminology.
Qualifications
  • Hands‑on Medidata Rave experience with proven ability to build EDC specifications from Day 1.
  • Minimum 6-7+ years of experience with a Bachelor's degree, or 3-4+ years with a Master's/Ph.D.
  • Strong working knowledge of Good Clinical Practice (GCP), ICH guidelines, and SDTM standards.
  • Excellent cross‑functional project management, communication, and team coordination skills.
  • Willingness to work onsite/hybrid in NJ or IL, or relocate if offered permanent FTE conversion.
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.

Inclusion Commitment

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.

Benefits

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).

Application Period

This posting is open for thirty (30) days.

Additional Qualifications
  • Hands‑on Medidata Rave experience with proven ability to build EDC specifications from Day 1.
  • Minimum 6–7+ years of experience with a Bachelor’s degree, or 3–4+ years with a Master’s/Ph.D.
  • Strong working knowledge of Good Clinical Practice (GCP), ICH guidelines, and SDTM standards.
  • Excellent cross‑functional project management, communication, and team coordination skills.
  • Willingness to work onsite/hybrid in NJ or IL, or relocate if offered permanent FTE conversion.
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