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Job #02545

About our client Our client is a privately held biopharmaceutical company headquartered in Los Angeles that is dedicated to the development and commercialization of protein and antibody-based therapeutics for the treatment of various diseases. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Trial Manager Los Angeles, California Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage the overall operation of the entire clinical study (project planning, budget, resource management and contract research organization and other vendor management) 2) Develop and maintain study timelines in accordance with the corporate goals and strategy 3) Manage the clinical operational plan and incorporate the study and scientific plan 4) Develop study related documents and overall direction for the clinical sites to establish protocol development 5) Ensure compliance with good clinical practices and regulatory guidelines 6) Recommend and implement innovative process ideas to impact clinical trials management 7) Develop and manage clinical study budget and develop contingency plans for clinical trials 8) Manage all aspects of clinical operational plan 9) Act as a cross-functional liaison to ensure that the study plan aligns with the business development strategies and members of cross-functional project teams 10) Manage the full scope of study, protocol and scientific publications 11) Lead the Project Clinical sub-team, by preparing agenda and minutes at leading meetings 12) Select, develop and evaluate personnel to ensure the efficient operation of the function Requirements 1) 3+ years of experience in clinical trials management 2) Biotech/pharmaceutical industry experience 3) Experience in Phase-I with experience in collaborating with cross-functional groups, including pre-clinical, bioassay, manufacturing and regulatory 4) Proven experience in writing or facilitating the development of clinical documents, including protocol development and informed consent 5) Experience in IND filings a plus 6) Experience managing study start activities 7) Start-up environment experience 8) Knowledge of oncology with proven experience in it 9) Ability to work with minimal supervision preferred