Associate Director, Project Manager
Clinical CRO offering product development, trial and drug safety management. Includes information on services, company background, careers and locations.
Thirty-plus years of experience in the academic, pharmaceutical and contract research industry. Five-plus years of clinical project management and vendor management. Ten-plus years of combined field and in-house clinical monitoring experience focused on Phase I-IV trials and investigational drug accountability. - Successfully managed 6 U.S. sites and a large clinical team for a Phase II vaccine study that delivered 720 subjects enrolled in 4 weeks (2018-2020). - Served on a team of cross-functional leads to develop and pilot a process for "Just in Time" site activation for a Phase III oncology study. A clinical site was activated 7 business days after a potential patient was identified and this led to first patient enrolled nearly 3 months ahead of the client's stretch goal (2017). This innovative process continues to deliver new and advanced cancer treatments. - Successfully led a team of CRAs across North America in monitoring and data cleaning efforts to meet two interim data extract deliverables in support of a New Drug Application (2015-2017). - Served as a Clinical Research Specialist and Sr. CRA across North America in support of early phase trials in Alzheimer's Disease and rare neurological diseases (2010-2015). - Successfully built a territory of Phase II/III investigators and clinical sites in the Midwest (2009-2010). - Served as project manager and lead CRA for single and multi-center Phase I trials in patients and healthy subjects across the United States (2007-2009). -Created and managed a study drug accountability and quality assurance program for over 125 in-house and off-site trials at the University of Wisconsin Hospital & Clinics and University of Wisconsin-Madison (2004-2007). -Served as project manager and sole monitor for a Women’s Health Initiative study conducted at three clinical sites (Madison, Wisconsin, Iowa City, Iowa and Portland, Oregon) that enrolled 2,000 subjects (2000-2004).
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