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Job #02899

About our client Our client is a small start-up biotech company located in the Midwest. They have a promising compound for age-related macular degeneration. They offer strong bonuses and stock options to their entrepreneurial employees. Position Location Project Leader Midwest Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage (comprehensively) Phase I – II clinical development studies with therapeutic expertise 2) Oversee the Clinical Project Team 3) Ensure detailed timeline development and maintenance 4) Assign roles and responsibilities 5) Oversee vendors 6) Manage budgets 7) Select investigational sites 8) Develop, attend and make presentations at company meetings 9) Manage study start-up and study conduct management (e.g., CRF review, IC development/review, enrollment tracking, query resolution process, etc.) 10) Participate in the submission of INDs, NDAs and/or ANDAs Requirements 1) Degree (4 year) 2) Experience in managing clinical trials and clinical trial resources with therapeutic expertise in Opthamology 3) Ability to present well to clients 4) Advanced understanding of cGCPs, FDA regulations and ICH guidelines