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.
Office-Based in St. Petersburg, Russia
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 in clinical trials
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, advanced Excel skills
Knowledge of basic statistical concepts
This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.