JOBSEARCHER

Angular/Python Developer

Job TitleClinical 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 Cffr Part 11, Alcoa+, Electronic Signatures, Immutable Audit Trails, Data Versioning/Lineage.