
1001 - 5000 employees
Founded 1996
đ„ Healthcare
đŒ Consulting
đŠ Logistics
Healthcare âą Consulting âą Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
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1001 - 5000 employees
Founded 1996
đ„ Healthcare
đŒ Consulting
đŠ Logistics
Healthcare âą Consulting âą Logistics
PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.
âą Lead and facilitate initial and ongoing study Risk Management âą Participate in selection and setup of the RBM platform âą Perform Centralized Monitoring for a study, including review of Key Risk Indicators, Statistical Analyses and Quality Tolerance Limits âą Present Centralized Monitoring analysis results to study teams and clients âą Manage issues in a cross-functional environment âą Develop and review study-specific Plans âą Set up and manage targeted SDV and monitoring strategy for a study âą Set up and manage Central Data Review activities in a study âą Contribute to proposals and bid defense meetings with information about Risk Based Monitoring services âą Communicate study challenges to the Clinical Data Science group and develop data-driven solutions
âą College/University degree or an equivalent combination of education, training and experience âą Clinical Study Lead/Manager experience âą Strong communication & presentation skills âą Leadership and ability to work independently âą Centralized Monitoring experience is a plus âą Critical thinking and analytical skills âą Ability to work with complex data and provide insight into risk reports and trends âą Ability to adapt to changing circumstances and learn quickly âą Knowledge of the process and functions in clinical trials âą Ability to understand the protocol and study-associated risks âą Full working proficiency in English; Spanish proficiency is a plus âą Proficiency in MS Office applications and Excel skills âą CV/resume must be submitted in English
âą Employees can work remotely âą Opportunity to work on the frontline of the industry âą Global helicopter view on each project
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