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Senior Manager, Clinical Program Job
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| Employer Name: BiotechCrossing |
SpiderID: 2343266 |
| Location: Lexington, Massachusetts |
Date Posted: 7/5/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Project Managers and CRAs.Responsibilities:* Manage Clinical Lifecyle Plan for relevant product or indication in keeping with corporate and department goals;* Participate in the design and development of clinical trial protocols; * Oversee the development of specific study documents e.g. informed consent forms, study guidelines, operations manuals; * Oversee / manage the overall activities of relevant CROs, core laboratories, drug supply forecasting and monitors either in-house or regionally based; * Chair or participate in meetings with clinical development team; clinical team and cross-functional program team; * Oversee and manage program specific budget. In conjunction with Clinical Contracts Analyst, facilitate the development of clinical trial agreements and other relevant documents; review and approve site budgets; * Oversee the evaluation of potential clinical investigators and sites. Develop / direct clinical monitoring plan and priorities; * Analyze and develop action plans to address protocol compliance, safety, data and administrative issues with investigational sites, CROs and / or regional monitors.* Oversee and assist with the development of the clinical components of regulatory submissions including, but not limited to: safety, interim and final study reports. * Provide mentoring, leadership and guidance, to Clinical Research Associates, Clinical Project Managers and administrative support staff assigned to clinical trials.
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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: |
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Web Site: http://www.biotechcrossing.com
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