Principal Clinical System Designer
Core
Design and implement advanced clinical systems to enhance trial design and execution, including CRF development, edit checks, and dynamic checks.
Role type
Principal Clinical System Designer
Builds
Clinical Data Management Systems (CDMS) components, Custom CRF screens, Edit Check and Dynamic Check specifications
Domain
Clinical Research / Healthcare Intelligence
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Clinical system design, CRF design, Edit check development, Dynamic check programming, Protocol interpretation, Change management, Library item management, Quality control reviews, Stakeholder negotiation, Post-production release management
Preferred skills
Data analysis, Clinical data management systems proficiency
Technologies
Medidata Rave, Veeva EDC
Responsibilities
Lead design and development of clinical systems aligned with study protocols, Consolidate and complete high-level system requirements documents, Copy and modify CRFs from standard libraries, Develop Custom CRF screens and specification documents, Perform quality control peer reviews of database specifications, Lead eCRF and specification review meetings, Program complex dynamic checks and discrepancy edit checks, Drive post-production database changes and release into production
Seniority
Senior, hands-on IC
