Clinical Database Programmer

Job Title: Clinical Systems / EDC Specialist (Medidata Rave)Location: Lake County / Irvine / Florham Park (Hybrid preferred; remote acceptableContract Length: 1 yearTeam OverviewData Science is a best-in-class team responsible for bringing people, process, and technology together to generate business value from clinical trials data. The team operates through execution and innovation to support program- and study-level accountabilities within Data and Statistical Sciences (DSS).Key ResponsibilitiesEDC Design & Delivery• Translate study protocol requirements into Electronic Data Capture (EDC) system design• Ensure use of common data standards across studies• Design EDC systems to optimize functionality, end-user experience, and data flow• Own on-time delivery of EDC builds, amendments, and system changes• Manage integrations between EDC and other systems (e.g., IRT)Study & Program Execution• Ensure TA- and program-level consistency across studies• Track study progress using project management tools• Anticipate risks to timelines or quality and develop mitigation plans• Ensure work products align with upstream and downstream dependenciesCross-Functional Collaboration• Partner with DSS and cross-functional stakeholders to meet study and program objectives• Influence team members without direct authority• Participate in innovation and process-improvement initiativesCompliance & Quality• Ensure adherence to federal and local regulations• Ensure compliance with GCP, ICH guidelines, SOPs, and quality standards• Stay current on evolving regulations and clinical development policiesRequired Skills & ExperienceCore Requirements• Medidata Rave Certification with 3+ years of hands-on study build experience• Strong communication and presentation skills• Ability to work in a fast-changing, evolving environmentTechnical & Clinical Expertise• 3+ years of clinical technology (EDC) experience or5+ years in a similar technical or clinical development role• Demonstrated understanding of the clinical trial process• Knowledge of CDASH and SDTM• Experience with common industry design and development tools• Experience with EDC integrations (e.g., IRT)Professional Skills• Strong analytical and problem-solving skills• Ability to manage multiple priorities and timelines• Proven ability to influence stakeholders without direct authorityEducation• Bachelor’s degree in Business, MIS, Computer Science, Life Sciences, or equivalent experience• Master’s degree preferredEEO:“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”