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Mgr, Clinical Operations Job
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| Employer Name: BiotechCrossing |
SpiderID: 2196179 |
| Location: San Diego, California |
Date Posted: 4/19/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Ensure study protocols, informed consent and other documents are complete and consistent with FDA regulations to ensure successful review by study site IRBs. Present and/or negotiate with FDA to gain approval or thorough review of clinical study protocols, data analysis and clinical summaries to assist with the FDA approval process. Develop a clinical study budget and manage study costs within that budget. Manage clinical studies with rigor, quality and sufficient detail to ensure complete and accurate data collection, QC, and record keeping throughout the trial. Prepare draft and final versions of clinical report summarizing the results of a clinical trial consistent with clinical and regulatory requirements for clinical reports. Identify opportunities and lead efforts to develop scientific abstracts, presentations, and manuscripts for publication of clinical trial data. Take on periodic departmental responsibilities to assist the Director, Clinical Affairs, including representing the department within Gen-Probe and at public meetings, including meetings with FDA. Provide guidance to junior staff personnel within the Clinical Affairs department. Performs other related duties as assigned. NOTES: Employer will assist with relocation costs. Salary is negotiable. Requirements The required skills, knowledge and abilities are typically acquired through a minimum of a BS degree in a life science or equivalent plus 10 years clinical research experience with in vitro diagnostics, therapeutic devices or drugs; or a MS degree in a life science or equivalent plus 8 years clinical research experience with in vitro diagnostics, therapeutic devices or drugs; or a PhD in a life science or equivalent plus 4 years clinical research experience with in vitro diagnostics, therapeutic devices or drugs. Demonstrated experience in technical writing and basic statistics as associated with clinical trial and/or research data and clinical or research reports presented to FDA and/or contained in a recognized scientific publication. Prior experience in negotiating and/or presenting clinical protocols or data to FDA. Must have prior experience in designing and managing successful clinical trials for in vitro diagnostics, therapeutic devices, or drugs, preferably in the areas of infectious disease, blood banking, oncology or others applications of nucleic acid amplification technology.
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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: - |
Company Type: Employer |
| Company: BiotechCrossing |
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| City: Pasadena |
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| State: California |
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Web Site: http://www.biotechcrossing.com
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