Company Description

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.

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 ManagementParticipate in selection and setup of the RBM platformPerform Centralized Monitoring for a study including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance LimitsPresent Centralized Monitoring analysis results to study teams and clients and manage issues in cross-functional environmentDevelop and review study-specific PlansSet up and manage targeted SDV and monitoring strategy for a studySet up and manage Central Data Review activities in a studyContribute to Proposals and bid defense meetings with information about Risk Based Monitoring servicesCommunicate study challenges to Clinical Data Science group and work out data-driven solutions

QualificationsCollege/University degree or an equivalent combination of education, training and experienceClinical Study Lead/Manager experienceStrong communication & presentation skills are essentialLeadership and ability to work independently are essentialCentralized Monitoring experience is a plusCritical thinking and analytical skillsAbility to work with complex data and provide insight into risk reports and trendsAbility to adapt to changing circumstances and learn quicklyKnowledge of the process and functions in clinical trials, ability to understand the protocol and study associated risksFull working proficiency in English and PolishProficiency 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.