PSI CRO AG
1001 - 5000 employees
Founded 1996
âïž Healthcare Insurance
đ Pharmaceuticals
đŹ Science
Healthcare Insurance âą Pharmaceuticals âą Science
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.
Central Monitoring Manager
đ April 24
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PSI CRO AG
1001 - 5000 employees
Founded 1996
âïž Healthcare Insurance
đ Pharmaceuticals
đŹ Science
Healthcare Insurance âą Pharmaceuticals âą Science
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.
đ Description
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 and manage issues in 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 Clinical Data Science group and work out data-driven solutions
đŻ Requirements
âą College/University degree or an equivalent combination of education, training and experience âą Clinical Study Lead/Manager experience âą Strong communication & presentation skills are essential âą Leadership and ability to work independently are essential 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, ability to understand the protocol and study associated risks âą Full working proficiency in English (Latvian proficiency is a plus) âą Proficiency in MS Office applications, Excel skills
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