I have 25 years of international development experience. I specialize in working with Startup/Virtual Companies to manage clinical trials with little/no CRO support. I have also managed many trials with CROs.As well, I have experience establishing and managing operations departments with up to 40 staff members and up to 25 ongoing trials. Project management, monitoring, co-monitoring and vendor management are some of my areas of expertise.I have spent my career managing global clinical trials in compliance with ICH-GCP/FDA regulations/guidelines and have been a Certified Project Management Professional since 2000. The following outlines areas of expertise: Clinical Operations:SOP developmentInfrastructure design & optimizationProcess optimizationInvestigator payments management & trackingBudget development & managementTMF design/managementHiring & team developmentProtocol & CRF design and optimizationProject Management:Development of PM best practicesTimeline development/managementGlobal/International PM experienceCRO Management:RFP designVendor selectionCRO rescueClinical Monitoring:On site & remote monitoringCRA Training/co-monitoringRegulatory:Managing Submissions in US, Canadian, EU, South America, Australia, South Africa and India.Investigational Product Packaging & Labeling:Process managementManagement of P/L vendorMid-study label modifications (expiration date updates etc.)Specialties/Therapeutic areas of expertise include:Oncology: NSCLC, Ovarian, Hodgkins, NHL, Multiple Myeloma, MDS and AML.Cardiovascular: Anti-Coagulants, Heart Failure, Unstable Angina,Acute Coronary Syndrome, Myocardial InfarctionNeurology: Acute Ischemic Stroke (Device)Hematology: Sickle Cell Disease, ThalassemiaCritical Care: Severe SepsisAutoimmune Disease: SLE, SjögrensAnti-Infectives: Chronic Bronchitis, Community Acquired PneumoniaFirst in Man: Single and Multiple Ascending Dose Studies

In charge of Clinical, Preclinical and CMC development in a virtual company.

Lived and Worked in Switzerland 1997-1999. Managed project managers and CRAs in various countries in Europe and Israel.