Central Monitoring Manager
PSI CRO
Bucharest, Romania
4 zile în urmă

Company Description

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.

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 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.

You will

  • 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
  • Qualifications

  • 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
  • Additional Information

    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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