[Remote] edc programmer

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