Clinical Systems Developer

Company: Sphinix Solutions
Location: Bethesda
Posted on: May 3, 2021

Job Description:

Bethesda , Maryland , United States - NIH - Contract 3+ years experience in an IT development role for clinical systems in the pharmaceutical/biotechnology industry is required
Practical experience working with Oracle Argus Safety is a must
Ability to create front-end advanced conditions including query sets and generate custom reports from the Argus database using ad-hoc SQL queries
Receive and respond to Argus Safety system user questions/ issues within SLA
Knowledge of processes and applications related to Clinical Operations, Clinical Science, Drug Safety and pharmacovigilance, etc. (e.g. Oracle Argus Safety, EDC, Empirica Signal, etc.)
Ability to troubleshoot issues and work independently with minimal direction
Knowledge of procedures and best practices related to GxP, system validation in a regulated environment
Working knowledge of Oracle database and PL/SQL programming
Working knowledge of MedDRA and WHODrug
Ability to conduct project specific configurations in Argus Safety (studies, products, report rules, periodic report configuration and generation)
Maintain and document system configuration of Argus Safety based on project requirements
Knowledge of E2B R2/ R3 specifications and Interchange with Argus Safety
Ability to work in native XML data when required
Knowledge of Omics data and integration

Education:

B.S. in Computer Science or related field

Keywords: Sphinix Solutions, Bethesda , Clinical Systems Developer, Healthcare , Bethesda, Maryland