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Central Monitoring Manager

Central Monitoring Manager

PSI CROPretoria, Gauteng, South Africa
28 days ago
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.

You will :

  • 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 meetings with information about Risk Based Monitoring services
  • Communicate study challenges to Clinical Data Science group and work out data-driven solutions

Qualifications :

  • College / University degree or an equivalent combination of education training and experience
  • Clinical Study Lead / Manager experience
  • Strong communication & presentation skills are essential
  • Leadership and ability to work independently are essential
  • Centralized Monitoring experience is a plus
  • Critical thinking and analytical skills
  • Ability to work with complex data and provide insight into risk reports and trends
  • Ability to adapt to changing circumstances and learn quickly
  • Knowledge of the process and functions in clinical trials ability to understand the protocol and study associated risks
  • Full working proficiency in English
  • Proficiency in 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.

    Remote Work : No

    Employment Type : Full-time

    Key Skills

    Cruise,Dcom,HVAC Design,Arabic,Asic

    Experience : years

    Vacancy : 1

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    Manager • Pretoria, Gauteng, South Africa

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