Type:

full-time

Job Description:

Location:

Branchburg, NJ preferred | Candidates near other company offices considered | Remote may be considered for an exceptional candidate

Contract Opportunity PAY:

$58-$62/hr Required Skills & Experience 6-7+ years of relevant EDC/study build experience, with approximately 8 years of Medidata Rave experience preferred. Strong, hands-on Medidata Rave experience. Demonstrated experience with EDC study design, database build, and study configuration. Experience developing EDC specifications and eCRFs based on clinical study requirements. Strong understanding of SDTM and downstream clinical data requirements. Experience supporting clinical trials and coordinating across Clinical Science, Clinical Monitoring, Statistics, Data Management, and other study functions. Understanding of downstream clinical systems and integrations, including eCOA and IRT/RTSM, and their impact on study build and go-live activities. Experience supporting study testing, validation, UAT, implementation, and/or go-live activities. Ability to work independently while effectively collaborating with cross-functional clinical study teams. Bachelor's degree required.

Preferred:

Veeva EDC experience, Phase I clinical trial experience, experience with internal study tracking/development systems, and therapeutic-area exposure within aesthetics/eye care, immunology, or oncology. Job Description We are seeking an experienced EDC Lead / Programmer to support clinical trial study design, database build, and EDC programming activities. This is a hands-on technical position for someone who has personally designed and built clinical studies within Medidata Rave and wants to remain actively involved in EDC development rather than move into a people-management or vendor-oversight role. The EDC Lead / Programmer will be responsible for the hands-on design, build, configuration, and implementation of EDC databases supporting clinical trials , with a primary focus on Medidata Rave.

Key responsibilities include:

Design and build clinical studies within Medidata Rave EDC. Develop and maintain EDC specifications, eCRFs, edit checks, study configurations, and associated database-build documentation. Translate clinical protocols and study requirements into effective EDC database designs. Support database testing, validation, UAT, issue resolution, and study go-live activities. Partner with Clinical Science, Clinical Monitoring, Statistics, Data Management, and other cross-functional stakeholders to ensure EDC requirements are accurately implemented. Coordinate EDC activities with downstream and integrated clinical systems, including eCOA, IRT/RTSM, and other clinical data sources. Ensure database design supports appropriate SDTM and downstream clinical data requirements. Support study amendments, database updates, and changes throughout the clinical trial lifecycle. Troubleshoot EDC build/configuration issues and provide technical solutions to study teams. Maintain accurate study documentation and ensure EDC deliverables meet applicable standards, timelines, and quality expectations. 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