Job Description
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
Numbers & Facts
| Location | Branchburg, NJ (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $42–$46 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
Skills
- Biologyunmatched
- Business Solutionsunmatched
- Clinical Dataunmatched
- Clinical Information Systemsunmatched
- Clinical Practices/Protocolsunmatched
- Clinical Trialunmatched
- Computer Scienceunmatched
- Electronic Data Capture (EDC)unmatched
- GCP (Good Clinical Practices)unmatched
- Maintain Complianceunmatched
- Management of Information Systems/Technology (MIS)unmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Standard Operating Procedures (SOP)unmatched
- Standards Developmentunmatched
- System Integration (SI)unmatched
- Systems Administration/Managementunmatched
- Systems Analysisunmatched
- Time Managementunmatched
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