In this role you will design and configure study data collection and specifications to support clinical trials, collaborating with cross-functional teams to ensure compliant, timely delivery. You will translate study protocols into CDMS configurations, author/edit data specifications, and manage study-related documentation and risks. You’ll contribute to project finances within programming shared services and lead design review discussions to drive accurate, scalable study builds. This position offers the opportunity to influence data capture standards and support continuous process improvements in a regulated environment.
Responsibilities
Interpret study protocol and translate into study design components
Design and update eCRF using CDMS tools aligned with SDTM/CDASH
Create and update Edit Specification Document
Generate specifications for EDC build components (Rights and Roles, System Settings, Home Page)
Lead/participate in design review meetings and edit spec discussions
Design databases to capture LLRR data within InForm with proper access controls
Communicate project risks and potential timeline impacts to Data Team Lead
Escalate quality issues and ensure training and SOP adherence
Review build timelines and project QIP, identify out-of-scope activities
Manage multiple study design projects across platforms and drive process improvements
Key requirements
Bachelor in Science/Computer science/Information Technology or Bachelor in Technology
2-4 years of relevant core technical designer experience
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