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Clinical Trial Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2208199 |
| Location: Fremont, California |
Date Posted: 4/29/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Design study documents including, but not limited to clinical protocols, case report forms, site study procedure manuals and project tools, monitoring plans, tracking tools, and informed consent forms. - Prepare and track timelines and required documentation from clinical sites and /or a full service CRO - Review and resolve discrepancies in clinical data with clinical sites or through a full service CRO. - Provide guidance, clinical trial management expertise, and direction to in-house and contract CRAs in the field. - Assist the senior management in review of clinical study reports, budget and contract negotiation. Assure regulatory compliance of investigational sites with company SOPs, FDA and ICH guidelines. - May be required to travel up to 30% Requirements - 3+ years monitoring; and 2+ years as a CRA at a sponsor company and CRO management experience. - Demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations and experience with all phases of a study (qualification through final study report generation). - BS in a scientific discipline, or health-related field, five or more years of relevant experience including leadership experience within clinical research. -CNS, CV and/or GI experience - Demonstrated problem solving abilities in overseeing clinical studies, and demonstrate tactfulness and diplomacy in dealing with study coordinators and physicians. - Advanced computer literacy required (e.g. MS Word, Excel, PowerPoint).
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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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| Zip: |
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Web Site: http://www.biotechcrossing.com
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