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 implementationInterpret clinical study protocols and translate requirements into EDC/database designsDevelop and maintain CRFs/eCRFs, EDC build specifications, edit checks, validation specifications, and related study documentationProgram, configure, review, and test edit checks and clinical database functionalityPerform User Acceptance Testing (UAT) and support study go-live activitiesManage database changes, protocol amendments, and system updates throughout the study lifecycleEnsure study builds align with established clinical data standards, including CDASH and SDTMSupport consistency of clinical database designs across studies and programsCoordinate with Clinical Science, Clinical Data Management, Monitoring, Biostatistics, Statistical Programming, and other cross-functional study teamsSupport integration and data flow between EDC and downstream clinical systems, including eCOA/ePRO, IRT/IVRS/IWRS, and randomization systemsTrack study-build timelines, deliverables, dependencies, risks, and issuesIdentify potential timeline or quality concerns and develop appropriate solutionsSupport database lock and other clinical data management activities as neededMaintain complete and accurate documentation in accordance with applicable SOPs and regulatory requirementsEnsure compliance with GCP, ICH guidelines, applicable regulations, and clinical development quality standardsContribute to clinical systems process improvements, standardization, and innovation initiativesProvide 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 discipline7+ years of relevant EDC/clinical database experienceExtensive hands-on Medidata Rave experience; approximately 8 years is highly preferredDemonstrated experience personally performing EDC study design and technical study buildsExperience developing EDC/eCRF build specificationsStrong knowledge of CDASHWorking knowledge and experience with SDTMStrong understanding of clinical trial processes and the clinical study lifecycleExperience with EDC testing, edit checks, UAT, study go-live, amendments, and database changesExperience coordinating technical deliverables across cross-functional clinical study teamsUnderstanding of clinical system integrations and downstream systems such as eCOA/ePRO and IRTStrong analytical, problem-solving, communication, and organizational skillsAbility to influence and coordinate across teams in a matrixed environment Preferred Qualifications Master's degree or PhDVeeva EDC experiencePhase I-IV clinical trial experienceExperience with clinical study tracking/development systemsExperience supporting clinical trials within pharmaceutical, biotechnology, or CRO environmentsTherapeutic-area experience in oncology, immunology, aesthetics, or eye care is a plus but not required By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy