The Fountain Group is currently seeking a Systems Designer / Analyst II for a prominent client of ours. This position is located in Branchburg, NJ . Details for the position are as follows:
Job Title: Clinical Data Systems Lead (EDC Study Build)
Location: Prefer New Jersey or near a client office (Open to remote candidates with strong experience)
Pay Rate: $42-$46/hr (W2)
Duration: 1 Year (Potential extension for a 2nd year)
Job Description
- Lead the design, build, and delivery of clinical trial systems, including EDC, IRT, and ePRO.
- Develop and implement common data standards across clinical studies.
- Perform hands-on technical study build in Medidata Rave while ensuring compliance with protocol and data standards.
- Ensure consistency of clinical system design across therapeutic areas and programs.
- Manage system integrations and coordinate required study updates.
- Track study build progress and ensure timely delivery using project management methodologies.
- Ensure compliance with GCP, ICH Guidelines, SOPs, and applicable regulatory requirements.
- Lead process improvement and innovation initiatives within Clinical Data Strategy.
Education
- Bachelor's degree in Business, Management Information Systems, Computer Science, Life Sciences, or a related field.
- Master's degree preferred.
Required Skills
- 7+ years of hands-on technical study build experience in Medidata Rave EDC
- Clinical Electronic Data Capture (EDC) system design and configuration
- CDASH standards
- SDTM standards
- Clinical trial system implementation (EDC, IRT, ePRO)
- Clinical data standards development
- Clinical trial process expertise
- GCP, ICH Guidelines, and clinical regulatory compliance
Preferred Skills
- Veeva EDC technical study build experience
- Clinical system integration experience
- Clinical Data Strategy process improvement and standardization
- Cross-study/program clinical system design expertise