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Reference # : 18-01374 Title : Clinical Research Study Manager
Experience Level : Start Date : 05/16/2018  
? Phase 1 experience ? Minimum 5 year's experience in clinical research management ? Oncology trail experience ? Global Trial experience ? Strong scientific background- academic or experience in clinical research setting. ? Protocol writing experience- a plus ? Strong authoring protocols experience in clinical study reports. Responsibilities: Planning, management and reporting of clinical studies conducted by Early Development or the Functional Service Provider through oversight of cross-functional study activities Identification and resolution of issues Communication of study timelines and deliverables ensuring studies are conducted in accordance with SOPs, GCP and regulatory guidance Contributing to the First in Human Portal document/Global Development Plan Contributing to/authoring protocols, relevant sections of annual safety reports, clinical study reports, and publications Management and/or oversight of study budget, timelines and insourcing/outsourcing partners to the required standards Preferred Qualifications: MS or RN 7+ years of experience in life sciences or medically related field 4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company Management experience of direct reports Experience in oversight of Functional Service Providers, outside vendors (CRO's, central labs, imaging vendors, etc) Basic Qualifications: Doctorate Degree OR Master's Degree and 3 years of Clinical experience OR Bachelor's Degree and 5 years of Clinical experience OR Associate's degree and 10 years of Clinical experience OR High school diploma/GED and 12 years of Clinical experience