
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 Streamline activities of project teams and ensure consistency of Clinical Operations processes across the Asia Pacific region âą Ensure project teams meet study milestones at country level âą Report study progress to clients and global stakeholders âą Act as project management contact for project teams and PSI support services âą Review study status and report progress; collect and report project status updates âą Develop and update project planning documents, essential study documents, and project manuals/instructions âą Ensure project timelines and subject enrollment targets are met âą Coordinate maintenance of study-specific and corporate tracking systems âą Oversee site selection and startup, contractual negotiations, and budget negotiations âą Supervise project team and site training; perform field training of monitors tailored to project needs âą Ensure team compliance with project-specific training matrix âą Supervise preparation, conduct, and reporting of site selection, site initiation, routine monitoring, and closeout visits âą Review site visit reports and ensure monitoring and reporting standards are met âą Oversee investigator and site payments âą Supervise project team preparation for study audits/inspections and resolution of findings âą Participate in regional project oversight for APAC as needed
âą MPharm, RN, or university/college degree in Life Sciences, or equivalent combination of education, training, and experience âą Minimum 4 years of site monitoring experience âą At least 2 years of experience as a Lead Monitor âą Experience supervising clinical project activities and leading clinical project teams âą Experience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or rare disease indications preferable âą Communication, presentation, and customer-service skills âą Team-building, leadership, and organizational skills âą Full working proficiency in English âą Proficiency in MS Office applications, including MS Project
âą Remote work âą Professional development and success investment âą Stable and secure workplace âą Inclusive culture âą Diverse and welcoming work environment
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