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Clinical Affairs Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2214595 |
| Location: Bedford, Massachusetts |
Date Posted: 5/6/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Ensure adherence to protocols and compliance with regulatory / FDA / ICH / GCP guidelines as well as SOP procedures. Develop SOPs and guidelines to assure internal files, site files and field data conform to Good Clinical Practice regulations and standards as well as applicable sections of 21 CFR Identify clinical training needs and develop training materials for in-house and clinical site use Develop, maintain and expand collaborations with outside clinical investigators, researchers and consultants to facilitate the optimum performance of clinical development programs Coordinate production, labeling and delivery of clinical supplies with Operations, external labeling company, and investigational sites. 20% - 40% travel required, dependent on number of on-going projects Coordinate with distributors on supervision of non-company-sponsored international clinical trials. Ensure appropriate regulatory agency approval of changes in investigational plans. Maintain the portfolio of clinical studies, providing periodic evaluation and problem identification and resolution, as necessary Supervisory Responsibilities: Supervises activities of external Contract Research Organizations and investigational sites. Requirements Experience, Knowledge, and Skills Required: BS or higher degree in the Life Sciences or related discipline. Minimum 5 years in biopharmaceutical or device industry, CRO or academic/hospital clinical research environment. 5+ years clinical monitoring experience. Required to have direct clinical research experience and to have supervised clinical studies as a project leader Solid experience leading the management of clinical trials (Phases I-III). Must have demonstrated experience & skills in getting clinical trials up and running and off the ground.
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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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