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Clinical Trial Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2203738 |
| Location: Fremont, California |
Date Posted: 4/25/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Perform independent monitoring of sites including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits. Maintain frequent contact with and work effectively with investigators and coordinators - 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.
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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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