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 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
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
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.