Central Monitoring Manager
Central Monitoring Manager
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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 riskbased 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 crossfunctional environment
- Develop and review studyspecific 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 datadriven 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 and Polish
- 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 riskbased models and get a global helicopter view on each project.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
