Solutions Design Analyst, Specialty Solutions
Core
Design clinical trial software solutions by mapping protocols to system configurations and ensuring data consistency for complex studies.
Role type
Solutions Design Analyst (Clinical Technology)
Builds
Configured clinical trial systems and specifications for sponsors
Domain
Life Sciences / Clinical Trials / eClinical Systems
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
Clinical protocol mapping, eClinical system knowledge (eCOA, ePRO, IRT/RTSM, eConsent), requirements gathering, specification creation, data structure validation, system configuration, defect resolution, process improvement, proposal analysis
Preferred skills
Academic background in Life Sciences or Computer Sciences, international experience
Technologies
eCOA, ePRO, IRT/RTSM, eConsent, Clario products
Responsibilities
Manage and coordinate the Solutions Design process to map clinical protocols to software solutions; Gather and document requirements and specify design components; Create and maintain specifications for study-specific implementations; Ensure consistency between trial data capture, data delivery, and database structures; Collaborate with Clinical Systems Translation to confirm correct versions of copyrighted questionnaires; Support Solutions Validation/Quality Control testing by addressing design defects; Collaborate with other departments to investigate study issues beyond startup; Provide input to interdepartmental process improvement initiatives; Collaborate with Clinical PM to ensure sponsor needs are met from a system perspective; Participate or lead design milestone meetings; Represent Solution Design in client audits to describe process flows; Partner with Business Development and Project Management to review proposals and protocols; Configure systems to map to configurational documents
