Systems Designer / Analyst III

The Fountain Group is a national staffing firm and we are currently seeking a ­­­­­­­­Senior EDC Programmer / Clinical Database Developer for a prominent client of ours.  This position is in Branchburg, NJ OR Remote Details for the position are as follows:

Senior EDC Programmer / Clinical Database Developer – Medidata Rave

Location: Branchburg, NJ preferred; candidates near other company locations may also be considered
Work Arrangement: Onsite/Hybrid preferred

Position Overview

We are seeking an experienced EDC Programmer / Clinical Database Developer to support the design, development, and delivery of clinical trial systems.

This is a hands-on technical role focused heavily on Medidata Rave EDC study design and build. The ideal candidate will have extensive experience personally designing and building clinical studies within Medidata Rave, developing EDC specifications, and partnering with cross-functional clinical study teams through study go-live.

This is not a people-management or vendor-oversight position. Candidates should have recent, hands-on experience building and configuring EDC studies.

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 SDTM

• Support consistency of clinical database designs across studies and programs

• 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

• Experience developing EDC/eCRF build specifications

• 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 with clinical study tracking/development systems

• Experience supporting clinical trials within pharmaceutical, biotechnology, or CRO environments

• Therapeutic-area experience in oncology, immunology, aesthetics, or eye care is a plus but not required

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