PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on 'on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that ...
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You will join a widespread, yet closely-knit team with the same mentality and desire to develop smart and intelligent approach to project monitoring. You will help to shape the future of effective risk-based monitoring at PSI and ensure higher quality of study data. You will spend time monitoring study data remotely, identifying errors and issues with site performance.
Hybrid position after trial period.
You will:
Review EDC, IxRS, Laboratory and other vendors’ 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
Qualifications
College/University degree or an equivalent combination of education, training & experience
Prior experience in Clinical Research
Experience in central monitoring and clinical data review is a plus
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
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