Central Monitoring Manager

  • Oxford, UK
  • Full-time

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.

    Office-Based in Oxford

    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 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

     

    Additional Information

    This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

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