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Manager, Clinical Data And Biostatistics Job
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| Employer Name: BiotechCrossing |
SpiderID: 2212521 |
| Location: San Diego, California |
Date Posted: 5/3/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
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. Provide technical and administrative assistance to all clinical studies. With regard to DM and data analysis concerns, assure regulatory compliance of vendors and investigational sites with company SOPs, FDA and ICH guidelines, and other applicable regulations and guidelines. Train and develop clinical staff on data management issues. Write and maintain appropriate data management SOPs. EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES REQUIRED: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Demonstrate ability to lead and motivate personnel. Must be familiar with all aspects of data collections and resolution in clinical trials. Requires effective time, cost and resource management skills. Knowledge of the pharmaceutical, biotechnology, biomedical, and/or clinical research industry. Working knowledge of word-processing and data management (Excel or Access) software. Ability to use SAS to program edit checks, provide summary listings and summary tables.
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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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