Systems Designer / Analyst III

Position Overview

The Fountain Group is seeking a Senior EDC Programmer / Clinical Database Developer for a prominent client. This role is based in Branchburg, NJ or remotely.

Key Responsibilities

• Lead hands-on Medidata Rave EDC study design, development, build, testing, and implementation
• Interpret clinical study protocols and translate requirements into EDC/database designs
• Develop and maintain CRFs/eCRFs, EDC build specifications, edit checks, validation specifications, and related study documentation
• Program, configure, review, and test edit checks and clinical database functionality
• Perform User Acceptance Testing (UAT) and support study go-live activities
• Manage database changes, protocol amendments, and system updates throughout the study lifecycle
• Ensure study builds align with established clinical data standards, including CDASH and SDTMS
• Coordinate with Clinical Science, Clinical Data Management, Monitoring, Biostatistics, Statistical Programming, and other cross-functional study teams
• Support integration and data flow between EDC and downstream clinical systems, including eCOA/ePRO, IRT/IVRS/IWRS, and randomization systems
• Track study-build timelines, deliverables, dependencies, risks, and issues
• Identify potential timeline or quality concerns and develop appropriate solutions
• Support database lock and other clinical data management activities as needed
• Maintain complete and accurate documentation in accordance with applicable SOPs and regulatory requirements
• Ensure compliance with GCP, ICH guidelines, applicable regulations, and clinical development quality standards
• Contribute to clinical systems process improvements, standardization, and innovation initiatives
• Provide technical guidance and mentorship to other team members while remaining actively involved in hands-on study development

Required Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Management Information Systems, Business, or a related discipline
• 7+ years of relevant EDC/clinical database experience
• Extensive hands-on Medidata Rave experience; approximately 8 years is highly preferred
• Demonstrated experience personally performing EDC study design and technical study builds
• Strong knowledge of CDASH
• Working knowledge and experience with SDTM
• Strong understanding of clinical trial processes and the clinical study lifecycle
• Experience with EDC testing, edit checks, UAT, study go-live, amendments, and database changes
• Experience coordinating technical deliverables across cross-functional clinical study teams
• Understanding of clinical system integrations and downstream systems such as eCOA/ePRO and IRT
• Strong analytical, problem-solving, communication, and organizational skills
• Ability to influence and coordinate across teams in a matrixed environment

Preferred Qualifications

• Master's degree or PhD
• Veeva EDC experience
• Phase I-IV clinical trial experience
• Experience supporting clinical trials within pharmaceutical, biotechnology, or CRO environments
• THERAPY-AREA EXPERIENCE IN ONCOLOGY, IMMUNOLOGY, AESTHETICS, OR EYE CARE IS A PLUS BUT NOT REQUIRED