PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.
Reporting to the Associate Director Risk-Based and Centralized Monitoring, the Clinical Data Scientist is an integral part of our team here at PSI. You will work with clinical trials patient and operational data, develop new data solutions and set up Risk-based Monitoring systems in Process Improvement department.
Based in Vienna
Project/ program assignments
- Participate in selection of the Risk-Based Monitoring (RBM) system and provide relevant training to the project team and/or Sponsor
- Set up and maintain RBM systems in collaboration with Central Monitoring Manager
- Establish data extract, load and transformation process for a study. Manage large complex datasets (including unstructured data) coming from multiple data sources. Map, mine and classify raw data and pull processed data into PSI data platform
- Program and produce data listings, tables and figures for Clinical Data Reviewers and Central Monitoring Managers
- Calculate Key Risk Indicators and Quality Tolerance Limits. Apply advanced analytical technics to identify data trends and patterns for Centralized Monitoring
- Collaborate with Central Monitoring Manger and cross-functionally to identify study challenges, develop an action plan and data solutions to address those using advanced analytics technics. Provide outputs actionable for project team
- Communicate and explain data findings and solutions to cross-functional stakeholders
Corporate/ departmental assignments
- Participate in development and programming of databases and software products for Centralized Monitoring
- Participate in development of processes, Quality System Documents (QSDs) and internal instructions for Centralized Monitoring