Central Monitoring Manager
PSI is a leading Contract Research Organization with more than 25 years on the market, 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.
With the industry moving forward, the central monitoring function has become a top priority at PSI. We are looking for a person, who would set the grounds for risk-based models on the clinical study level, mitigate data quality issues, and streamline monitoring, while ensuring patient safety and valid study results.
- Facilitate risk assessment, identify issues & critical data before and during study conduct
- Develop and review study-specific Monitoring Plans
- Select and setup RBM system; deliver relevant training to project teams
- Monitor aggregated patient and site data using technology
- Conduct root cause analysis of risks during study conduct
- Support Project Managers and Site Monitors in optimizing source data verification and site visit schedules
- Maintain documentation of central monitoring activities
- Contribute to Proposals and bid defense meetings with information about Central Monitoring services
- College/University degree or an equivalent combination of education, training and experience
- Experience in central monitoring or Lead CRA experience
- Knowledge of clinical trial process, ability to understand the protocol and study associated risks
- Critical thinking and analytical skills
- Ability to work with complex data and provide insight into risk reports and trends
- Communication skills, ability to explain complex concepts
- Full working proficiency in English
- Proficiency with MS Office applications, Excel skills
This role is not only important for every CRO, but it is booming now. This is an opportunity to work on a frontline of the industry, set the grounds for risk-based models and get a global helicopter view on each project.
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