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Director, CRA: ex-MedImmune 20+ years of experience in Clinical Research Management; Reduced single batch costs by more than $10K, an annual cost savings of $700K; Increased revenue of $0.5M to the bottom line of the company; Managed technology transfer to manufacturing and validated the processes; Negotiated site budgets averaging $25K - $40K; FDA, GMP, CAPA, SOP, AOAC, CK-MB, R&D; MS
Clinical Project Manager: ex-PRA International 15+ years of experience in Clinical Project Management; Reduced turnover from 45% to less than 12% within 18 months by creating new performance tracking systems; Submitted 100% of monitoring reports within SOP guidelines; Identified and trained 15 regional CRAs and opened 7 of 80 sites within just 4 weeks; Expertise in oncology, cardiovascular, central nervous system, immunology, dermatology and hematology trials; SOPs, GCP, FDA, ICH; PhD in Biochemistry
Regional Sales Manager: ex-Zeneca 10+ years of experience; Proven sales record in marketing cardiovascular, pulmonary and oncology products to physicians, medical groups and hospitals; Track record of being in the top 7 for 3 consecutive years; Increased sales revenues by 150% in assigned area by developing a new DTC marketing program; IHC, FCR, PDE, SKU; Bachelor's degree
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