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Clinical Trial Manager II/III Job
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| Employer Name: BiotechCrossing |
SpiderID: 2221060 |
| Location: South San Francisco, California |
Date Posted: 5/12/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
Perform job duties with minimal guidance from the Clinical Program Manager Lead the Protocol Execution Team (PET) to ensure that trial timelines, costs and quality metrics are met Serve as primary contact for functional area representatives in managing protocol execution Ensure accuracy and timeliness of vendor and site payments Oversee forecasting of clinical/non-clinical supplies Establish study milestones and ensure accurate tracking and reporting of study metrics Manage trial-specific Genentech collaborations with other research entities (e.g. Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials) Perform ongoing vendor management (e.g. CROs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management and issue resolution Create and manage clinical trial budgets and staffing/resourcing plans Provide study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate Provide support and mentoring to other Clinical Trial Managers Ensure trial adherence to ICH/GCP/local regulations Participate in clinical operations initiatives and programs as assigned Requirements Bachelors degree with a minimum of five years of clinical research experience for CTM II and minimum of seven years of experience for CTM III Therapeutic knowledge preferred Knowledge of GCP and ICH Proficient computer skills Travel may be required Highly developed leadership skills to build and direct the Protocol Execution Team to ensure that timeline, cost and quality metrics are met Effective written and verbal communication skills.
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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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