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Manager, Clinical Research Associates Job
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| Employer Name: BiotechCrossing |
SpiderID: 2267924 |
| Location: San Jose, California |
Date Posted: 6/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 5299242 |
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Job Description:
Responsibilities: The CRA Manager will report to the Director of Clinical Operations, and will have supervisory responsibility within the CRA arm of the Medical Affairs & Clinical Operations Department in San Jose, CA. The Clinical Operations, CRA group has responsibility for developing, executing and reporting clinical trials to establish the safety and efficacy/substantial equivalence of new or modified products, justify labeling and promotional claims, and evaluate potential product defects or malfunctions for products. CRAs in the clinical operations group are responsible for writing protocols, overseeing the progress of clinical trials, and ensuring that trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures, GCP, and the applicable regulatory requirements. Ability to travel up to 30% of the time, mostly within the US Requirements EDUCATION/SKILLS: Excellent interpersonal skills, including the ability to perform well in a highly matrixed environment, and serve as an effective leader of highly functioning multidisciplinary teams. Excellent written and verbal communication skills, should be highly organized, dynamic, confident, energetic, creative, disciplined yet open to new experiences and ideas. Thorough, demonstrated knowledge of Good Clinical Practices and other Regulations and Guidances relative to the conduct of clinical trials worldwide. Demonstrated proficiency in using Word Processing, Spreadsheets and Databases. Must possess the following core competencies: Integrity and Trust, Interpersonal Savvy, Listening, Dealing with Ambiguity, Decision Quality, Conflict Management, Maintaining Objectivity. Must have a minimum of a Bachelor's degree, 8 years direct clinical trials experience, and 2 years of supervisory/management experience. A proven track record in conducting complex clinical trials is preferred. Individuals with an advanced degree in Laboratory Medicine, Nursing, Pharmacy, or other health-related field highly desired. Prior experience within the Pharmaceutical or the Medical device industry, including the proven ability to direct clinical research teams in the conduct and reporting of multi-center, complex studies desired. CRA certification is highly desirable. Demonstrated Project Management capabilities, negotiating skills and conflict resolution abilities needed For immediate consideration, we encourage you to apply using our online candidate profile.
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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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: 91101 |
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Web Site: http://www.biotechcrossing.com
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