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Director of Project Management – Anne McCormick
Includes clinical operations, outsourcing, quality, vendor management

More than 15 years of clinical operations, regulatory compliance and project management experience in pharmaceutical companies, clinical research organizations and academic institutions

  • Concurrent position: Adjunct Faculty teaching Clinical Research courses for Raritan Valley Community College Allied Health Program
  • Associate Director, Clinical Operations and Project Management (CNS Neuroscience) Novartis Pharmaceuticals (CNS protocol assessments, site selection, trial enrollment, recruitment strategies, CRA training, tracking and maintaining metrics for all trial activity milestones)
  • Senior Project Manager (Cardiovascular) Pfizer Pharmaceutical Group. Led global and US project Teams for multiple Lipitor® clinical trials.
  • Regulatory Compliance manager for Clinical Quality Assurance unit: managed 7 auditors and QA staff. Collaboration with Regulatory Affairs and Legal Departments. Supported NDA and IND filings. Coordinated FDA Clinical Site inspections US and Europe
  • Project Management Consultant, Warner Lambert/Pfizer
  • CRA for Target Research Associates, a clinical research organization (therapeutic areas including Pain, Respiratory, Anti-infective, Obstetrics/Gynecology and Oncology)
  • QA and Regulatory Consultant for Schering-Plough Research Institute and Grünenthal GmbH
  • Program planning for international health programs GTZ and WHO
  • Adjunct Faculty University of California, Los Angeles School of Medicine, Doctoring Program
  • BA Pennsylvania State University. MSW California State University (Sacramento, CA) Post-grad courses part of QA/RA Masters Program Temple University


 
Somnus Therapeautics Insomnia
Somnus Therapeautics Insomnia