Central Monitoring Manager

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 (Latvian proficiency is a plus)

- 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.

PSI is a leading Contract Research Organization with almost 30 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.

Originally posted on Himalayas