Clinical Study Manager
Bonafide Staffing is looking for an experienced Clinical Study Manage with Oncology! Will assist in planning, initiating and executing clinical studies, budgets, timelines and resources for assigned trials. Provide support in managing day to day operations of assigned studies to ensure completion in compliance with GCP/ICH guidelines and other regulatory requirements. Provide accurate and up-to-date study information and other relevant tracking systems and provide regular updates of study progression to Clinical Program Management. Participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team deliverables. Must be have a solid CRA/Monitoring background and a must have a few years of working experience in Pharmaceutical and or CRO organizations. Requirements MS in Health Sciences w. at least 2 years of clinical trial Phase IV experience, Must have strong knowledge of protocol and clinical drug developments processes, clinical study design, study planning/management and monitoring Help with feasibility assessment/selection of countries/sites for study conduct and oversee the clinical aspects of timely data cleaning, data analysis and participate in data reviews and review of statistical analysis plans. Relocation is not available for this position, welcome all IL candidates. Possibility working from home 2 days a week, after a few months on-site
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