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Clinical Project Manager, Clinical Development: ex-MDS Pharma Services Liaised between seventeen physicians and the department staff (4 – 5 employees) and chairing committee meetings on a monthly basis; Expertise in providing operational expertise to the Study Team for complex/multiple studies including contract negotiations, enrollment, IRB submissions and approval, SAE reporting, compliance with ICH/GCP guidelines and Federal regulations; SAE, ICH/GCP; 15+ years of experience; Master’s degree in Public Health
Manager, Quality Control Laboratory: ex-Abbott Laboratories Implemented system for monitoring Key Performance Indicators and introduced numerous method changes within laboratory operation which resulted in significant cost savings; Seasoned leader in auditing, experience with GMP, GLP practices and well as developed several analytical test methods using HPLC, GC and FTIR techniques; 10+ years of experience; GMP, GLP; MS in Chemical Engineering
Scientist 1: ex-GlaxoSmithKline Mentor for new employees; In-depth experience of writing SOPs, study plans for studies according to ICH guidelines, perform autoclave testing as well as administered vaccinations, provided animal husbandry care, assisted in breeding and whelping; ICH, SOPs; 15+ years of experience; BS in Small Animal Science
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