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Job #02569

About our client Our client acquires, develops, and commercializes innovative products for the treatment of infectious diseases such as HIV/AIDS, hepatitis and other associated infectious conditions. They bring to the table a strong management team with a wealth of knowledge in multiple therapeutic areas. Position Location Manager, Clinical Operations New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Assist protocol development and writing 2) Prepare budgets for clinical trials, development programs and the annual budget 3) Assist in developing and writing SOPs 4) Participate in preparation of IND, Investigator Brochure, Annual Report and other relevant documents 5) Assist in CRO identification and selection process 6) Participate in the preparation of the clinical development plan for therapeutic compounds in development 7) Assist in the preparation of 'Requests for Proposal' documents and the financial analysis of CRO proposal costs 8) Plan, implement and manage, in collaboration with CRO partners, pre-clinical and Phase I-III clinical trials, as necessary 9) Assist in preparing timelines for the clinical trials comprising the development program 10) Perform resource assessments, allocation and management for all ongoing and planned clinical trials 11) Work with Clinical, Regulatory and CRO teams to ensure that clinical trials are completed on time, within budget and meet corporate/departmental objectives 12) Hire, train, manage and mentor departmental staff 13) Evaluate systems and processes to ensure standardization within the department and optimal efficiency, quality and compliance with regulatory guidelines Requirements 1) Bachelor of Science or a degree in a field relevant to the biopharmaceutical industry 2) Minimum 7 years of experience working in project management and/or clinical operations with a CRO and/or biopharmaceutical company 3) Project management and CRO supervisory experience 4) Experience in HIV 5) Experience in oncology a plus 6) Current knowledge of ICH/GCP guidelines