Note: The job is a remote job and is open to candidates in USA. Randstad USA is a top-tier global pharmaceutical leader, and they are seeking a Clinical Systems Designer / EDC Study Builder to drive innovation in clinical trial data systems. This role involves designing clinical systems and ensuring compliance with global data standards while mentoring team members.
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
Skills
- 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
- Master's degree
- Experience with Veeva EDC technical study builds
- Deep knowledge of SDTM standards
Benefits
- Medical
- Prescription
- Dental
- Vision
- AD&D
- Life insurance offerings
- Short-term disability
- A 401K plan (all benefits are based on eligibility)
Company Overview
Company H1B Sponsorship