![]() ![]() Experience developing clinical trial plans including site monitoring, risk mitigation strategies, trial budgets and site selection/feasibility.Minimum of 5 years experience in clinical research.Bachelor’s degree in a science or health-related field.Maintain knowledge of industry and regulatory trends as required to meet business needs and perform the responsibilities of the position. ![]() Participate in process improvement efforts.Manage non-compliance for resolution and prevention.Develop Study Reports and provide clinical portions for Regulatory submissions.Track and report progress of studies to applicable internal stakeholders, to include patient screening, enrollment, data collection, protocol compliance, device accountability, adverse event documentation and reporting.Oversight of clinical studies to include activities of site monitors, clinical vendors, review and approval of site visit reports, selection and coordination of DSMB / CEC / Steering Committees, and participation in site visits as necessary.Develop and approve study-specific documents, tools, presentations, and processes.Responsible to ensure clinical study meets timelines, quality standards and projected cost estimates.Provide study leadership within the project team to foster inclusive teamwork, cooperation and to provide strategic direction on operational study needs.Lead the activities of interdisciplinary Gore team members: plan, execute, and close complex global clinical studies.
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