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.

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 (Spanish proficiency is a plus)

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 integral helicopter view on each project.

📌 Central Monitoring Manager (Madrid)
🏢 Psi Cro
📍 Madrid