πUnited States
Clinical Data Reviewer

PSI CRO AG
πRemote - Brazil
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Summary
Join a widespread, yet closely-knit team focused on developing a smart and intelligent approach to project monitoring. Help shape the future of effective risk-based monitoring, ensuring higher quality study data. Monitor study data remotely, identifying errors and issues with site performance. Review data from various sources, generate and follow up on data queries, identify protocol deviations, and assist with administrative activities. Ensure site monitors receive information on site-related risks and issues, escalating findings to study teams. Assist with root cause investigation and follow up on site performance signals.
Requirements
- College/University degree or an equivalent combination of education, training & experience
- Prior experience in Clinical Research
- Full working proficiency in English
- Proficiency in MS Office applications
- Analytical mindset and attention to detail
- Ability to learn, plan and work in a dynamic team environment
Responsibilities
- Review EDC, IxRS, Laboratory and other vendorsβ data and clinical listings
- Identify single errors and systematic issues related to site performance
- Generate, follow up and resolves data queries and site issues
- Identify and record protocol deviations
- Assist to Central Monitoring Manager with administrative activities, including managing study data, documents and reports
- Ensure site monitors receive information on site related risk & issues. Escalate findings to study teams
- Assists with root cause investigation and follow up on site performance signals identified during central monitoring review
Preferred Qualifications
Experience in central monitoring and clinical data review is a plus
Benefits
Professional development
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