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Manager, Clinical Data And Biostatistics Job
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| Employer Name: BiotechCrossing |
SpiderID: 2217355 |
| Location: San Diego, California |
Date Posted: 5/8/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Assist in design and printing of case report forms (CRFs) for clinical studies. Assist in the development of data management and statistical analysis plans (SAPs), generally consisting of the review and finalization of SAPs provided to Halozyme from vendors. This includes review and finalization of shells for all data tables, figures, and listings. Interact with biostatisticians, data managers, CRA's, programmers, etc., to expedite and assure the flow of data between study sites, the data management group, and Halozyme. Coordinate the transfer of clinical data between all parties participating in a clinical trial, including vendors (e.g., central laboratories). Collaborate with contracted vendors the transfer of clinical lab and PK/PD data between sites, vendors and Halozyme. Manage and oversee contract research organizations handling clinical and PK data. Audit potential data management vendors, as appropriate, and verify and review validation of programs. Contribute to the review and query of clinical data. This includes the critical review of data-populated tables, figures, and listings as part of the database clean-up and prior to database lock. Assist in the compilation of clinical data for regulatory submissions, including AE listings, etc.
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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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