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Job #02491

About our client Our client is the world leader in the blood testing and screening business. Position Location Manager, Clinical Research for Molecular Diagnostics Northern California Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in project teams to provide input to research and development on trial designs for alpha and beta trials 2) Oversee the execution of trials that are done at outside facilities 3) Develop specific expertise and a comprehensive understanding of the specialty fields in the investigation of IVD products 4) Establish department procedures, SOPs and guidelines for conducting clinical trials and maintaining all required documentation files 5) Develop relationships with outside investigators who will provide clinical expertise and clinical samples for studies 6) Design and manage new or ongoing clinical trials with rigor, quality and sufficient details 7) Ensure complete and accurate data collection, QC and maintain record keeping throughout the trial 8) Solicit and negotiate clinical study budgets and clinical research contract with clinical sites and principal investigators 9) Ensure study protocols, informed consent and other documents are complete and consistent with FDA (and international regulations, as appropriate) 10) Ensure successful review by study site IRBs 11) Present and/or negotiate with FDA to gain approval or thorough review of clinical study protocols, data analysis and clinical summaries 12) Assist the FDA approval process 13) Prepare draft and final versions of clinical reports summarizing the results of a clinical trial consistent with clinical and regulatory requirements 14) Identify opportunities and lead efforts to develop scientific abstracts, presentations and manuscripts for publication of clinical trial data 15) Perform other related duties as assigned Requirements 1) B.S./M.S. in Biomedical Sciences or a related field, with 2 or more years of experience in research and development of medical products 2) 5-7 years of experience in clinical research within vitro diagnostics or therapeutic devices 3) Experience in working with external partners (preferred) 4) Demonstrated experience in technical writing and basic bio-statistics 5) Experience in designing and managing of successful clinical studies for 6) CBER as well as CDRH products preferred 7) Experience in molecular diagnostics development and clinical trial preferred 8) Knowledge/ experience in infectious disease, oncology and/or molecular diagnostics 9) Knowledge and experience in typical clinical trial databases such as SAS, etc. 10) Good interpersonal skills 11) Requirement three