Clinical Systems Developer


Founded in 1979, Technical Resources International, Inc. (TRI) is a full-service contract research organization plus (CRO+) providing product development support services to the global drug, biologic, and medical device community through the effective combination of scientific, clinical information technology, and communications services. TRI, Inc. is currently seeking a Clinical Systems Developer.


 


Responsibilities


 


Design and develop activities for clinical systems with a focus on drug safety and clinical trial management tools for Title 21 CFR Part 11 compliance, including:


 


  • Working closely with IT colleagues and Data Management and Trial Operations teams to implement solutions and customizations to the company’s established Safety (ARISg, Argus Safety suite) and CTMS (Medidata) products
  • Participating in all areas of the project lifecycle including analysis, design, development, implementation, support and enhancement

 




Requirements


 


  • Bachelor’s degree in computer science or a related field
  • 3+ years’ experience in an IT development role for clinical systems in the pharmaceutical/biotechnology industry
  • Practical experience working with the Oracle Argus Safety application
  • 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 the service-level agreement (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 Global reference site
  • Ability to conduct project specific configurations in Argus Safety (studies, products, report rules, periodic report configuration and generation)
  • Experience maintaining and documenting 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
  • Knowledge of STDM transmission
  • Excellent oral and written communication skills

 


Technical Resources International is fully committed to Equal Employment Opportunity and to attracting, retaining, developing and promoting the most qualified employees without regard to their race, gender, color, religion, national origin, age, physical or mental disability, veteran status, or any other characteristic prohibited by state or local law.


Publicado Ayer
Puedes ver otros empleos de aquí
Cargando