Central Monitoring Manager - Paris, France - PSI CRO

PSI CRO

Entreprise vérifiée

Paris, France

il y a 2 semaines

Posté par:

Sophie Dupont

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Description

Company Description

We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do.

A dynamic, global company founded in 1995, we bring together more than 2700 driven, dedicated and passionate individuals.

We work on the front line of medical science, changing lives, and bringing new medicines to those who need them.

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 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

Additional Information

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

Advance your career in clinical research and develop new skillsets whilst growing with the organization