Angular/Python Developer

Clinical Protocol & Study Design: Protocol Digitization, Protocol Authoring, Study Builder/Designer, Schedule of Activities (SoA), Study Schema, Eligibility Criteria, Arms/Cohorts, Clinical Endpoints, Study Amendments. Data Standards: CDISC, USDM (Unified Study Definitions Model), CDASH, ODM.Regulatory & Compliance Concepts: GxP, CSV (Computer System Validation), 21 CFR Part 11, ALCOA+, Electronic Signatures, Immutable Audit Trails, Data Versioning/Lineage.