Vacancy Description
Job Description
With the industry moving forward, the central monitoring function has become a top priority at PSI. We are looking for a person, who would lead the risk‑based monitoring approach implementation on the clinical study and program level to ensure patient safety and data integrity.
Responsibilities
- Lead and facilitate initial and ongoing study Risk Management
- Participate in selection and setup of the RBM platform
- Perform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits
- Present Centralized Monitoring analysis results to study teams and clients and manage issues in cross‑functional environment
- Develop and review study-specific Plans
- Set up and manage targeted SDV and monitoring strategy for a study
- Set up and manage Central Data Review activities in a study
- Contribute to Proposals and bid defense meetin...
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