and rules in EDC, as well as understanding how data is managed, cleaned, and reported Strong understanding of data management standards and guidelines (GCDMP, CDISC, SDTMIG, CDASH) Experience in a customer-facing role, preferably with a software professional services or consulting organization Proven track record of meeting project timelines/ more »
or CRO industry working ICH/GCP guidelines. Experience in both paper and electronic TMF, and familiarity with naming and filing conventions and the CDISC TMF Reference Model and applicable industry guidelines Experience in QC, maintenance of trial tracking sheets and databases and of preparing documentation for archiving. Proven ability more »
applications using SOAP/REST/GraphQL/JasonPure APIs Project Management experience for enterprise software implementations Document/Data migration experience Familiarity with CDISC, ODM and other data management industry standards SaaS/Cloud experience in the delivery of clinical trials Experience with source code control systems Amazon Web more »
