Maria Jose Manson
Research Practice Manager, Duke Office of Clinical Research @Duke University School Of Medicine
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WORK HISTORY
Research Practice Manager, Duke Office of Clinical Research @Duke University School Of Medicine
Durham, NC, US
Successfully manage and streamline cross-functional projects and processes, delivering innovative solutions that enhance operational efficiency and institutional effectiveness-Co-founded and led the establishment of a strategic COVID Research Program and outpatient facility, achieving significant organizational growth and optimizing participant recruitment and engagement-Directly oversee a team of 15 staff members, providing leadership in performance management, professional development, and career progression-Develop, implement, and maintain Standard Operating Procedures (SOPs) and Corrective and Preventive Actions (CAPAs) to ensure compliance with industry regulations and uphold the highest quality standards-Prepare and present comprehensive research findings and strategic recommendations to the executive team, driving informed and impactful decision-making-Build and maintain productive partnerships with industry sponsors and contract research organizations (CROs), leading feasibility assessments and identifying qualified investigators and study teams for industry-sponsored trials-Provide oversight for external research monitoring activities, ensuring strict adherence to institutional policies and regulatory requirements-Collaborate with institutional departments to develop project timelines, align budgets, and establish key performance metrics to assess project feasibility and success-Guide clinical research teams in audit preparedness and response, ensuring compliance with oversight entities, including Human Subject Research Compliance, sponsors, and the FDA.
EDUCATION
The Graduate School at UNC Pembroke
Master of Business Administration - MBA, Business Administration and Management, General
Universidad Hospital Italiano de Buenos Aires
Associate’s Degree, Surgery, Nursing, Medical Technology
Pfeiffer University
Bachelor in Science, Business Management and Leadership
SKILLS
ABOUT MARIA JOSE MANSON
Highly experienced Clinical Research Professional with over 20 years in Health Care Centers and Academic Institutions across the US and Latin America. Proven expertise in cross-functional collaboration, clinical trial planning, IRB/FDA regulations, and leadership. Field Clinical Specialist specializing in the operating room with 10+ years of experience. Clinical Research Consultant for pharmaceutical and medical device companies. Strong track record of success in managing projects, driving efficiency, and fostering excellence.
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