Note: The job is a remote job and is open to candidates in USA. Sriven Systems Inc. is seeking an EDC/Medidata RAVE System Designer/Programmer to lead clinical system design and study builds. The role focuses on governing clinical data standards, coordinating with cross-functional study teams, managing EDC and related system delivery, and ensuring compliance with FDA regulations, GCP, ICH guidelines, and internal SOPs.
Responsibilities
- Governed clinical data standards to ensure full compliance across system designs, study protocols, and enterprise data models
- Established system design methodologies to optimize functionality, user experience, and end-to-end data flow
- Enforced Therapeutic Area (TA) and program-level consistency across cross-functional design teams
- Managed on-time delivery and integration of clinical systems (EDC, IRT, ePRO), resolving timeline risks proactively
- Partnered cross-functionally to align system deliverables with upstream dependencies and downstream reporting
- Maintained strict adherence to FDA regulations, GCP, ICH guidelines, and internal SOPs to ensure audit readiness
Skills
- • This is a system design role
- • EDC Programmer/EDC Lead kind of profiles are required
- • Must have exp. with Medidata RAVE
- • Must have exp. with EDC (Electronic Data Capture)
- • Able to coordinating with other team members such as Statistician, programmer
- • Must have exp. with CDASH and SDTM control terminology
- • Protocol trading skill set is required
- • TA: SkinCare, EyeCare, Specilaity Phase I, Immunology, Neurology and Oncology
- • Must have prior leadership level exp. so that they will able to work with the study team
- • Must have good understanding of GCP and ICH guidelines
- • Bachelor's degree in business, management information systems, computer science, life sciences or equivalent
- • Must have 7+ years of hands-on technical Study build in EDC
- • Experience with technical study build in Medidata RAVE is required
- • In-depth knowledge of clinical trial processes
- • In-depth knowledge of CDASH (Required) and SDTM
- • Demonstrated performance as a key contributor to initiatives and advancement of the organization
- • Prior exp. with Veeva Vault would be nice to have
- • Masters preferred
- • Veeva EDC technical study build experience is a plus
Benefits
- Remote work arrangement
Company Overview
Company H1B Sponsorship