Allentown, Pennsylvania, United States
Experienced, degreed, clinical trial professional with 13 years of experience working on cell therapy studies, cartilage replacement studies, dermatology, oncology, pain management, neuropathy, and heart failure studies from phase 1-through early access. I am passionate about helping people live healthier, quality lives. Having worked with federal, state, local officials on environmental and wildlife issues with groups such as The Nature Conservancy, the Sierra Club, Penn Future, WWF, NWF, Oceana, Defenders of Wildlife, and the knowledge to know how the regulatory process works at the state and federal level, I am passionate about helping to conserve our natural resources.
Design and execute studies that comply with regulations and meet the company’s commercial goals. Set goals and timelines for study activities and provide oversight to ensure they are met. Serve as liaison for clinical trial-related information. Manage global clinical trials. Implement process improvements. Develop materials for use in clinical trials. Work closely with Study teams, Cook Research Inc./William Cook Europe, CRO, Vendors, Field Product Specialists, Product Managers, Marketing, MyoSite management, Internal Myosite departments (PL, QA, PD, Regulatory) and Sites Attend trainings, conferences, seminars
Lead cross-functional teams on tight timeline driven clinical research studies - Conduct protocol trainings for CRA's Work with outside vendors, sponsors, central labs, IRB to meet project initiatives, goals -review study docs, forms, revise, regulatory docs, source documents - Management of project budget - Support outside contract/supply agreement contract development and supplier management - Challenge functional groups to meet project goals and commitments - Provide routine project status communications to project team and management