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Senior Manager, Clinical Program Job
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| Employer Name: BiotechCrossing |
SpiderID: 2346794 |
| Location: Lexington, Massachusetts |
Date Posted: 7/7/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
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. Requirements Education & Experience Requirements:Bachelors degree in health sciences or related field, required; Master\'s preferred. Minimum 6-8 years clinical research experience in pharmaceutical or biotechnology fieldMinimum 2 years project management experience in clinical research environment including leading and/or managing staff directly.Key Skills and Competencies:Client focused approach with excellent oral, presentation and written communication skills.Excellent judgment and decision making skillsDemonstrated organizational and negotiation skills.
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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Web Site: http://www.biotechcrossing.com
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