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Clinical Trial Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2382505 |
| Location: South San Francisco, California |
Date Posted: 7/21/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6343381 |
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Job Description:
Summary of Position: The Clinical Trial Manager III is accountable for the day-to-day operations of 1-4 clinical trials commensurate with complexity, including trial start-up, conduct, and close-out activities. Job Duties/Responsibilities: - Performs job duties independently with minimal guidance from the Clinical Program Manager. - Leads the Protocol Execution Team (PET) to ensure that trial timelines, costs, and quality metrics are met - Serves as primary contact for functional area representatives in managing protocol execution - Ensures accuracy and timeliness of vendor and site payments - Oversees forecasting of clinical/non-clinical supplies - Establishes study milestones and ensures accurate tracking and reporting of study metrics - Manages trial-specific Genentech collaborations with other research entities (e.g., Cooperative Group Trials, Investigator Sponsored Trials, Global Partner Trials) - Performs ongoing vendor management (e.g., CROs, IVRS, Reading Centers), including independent negotiation of vendors scope of works and budgets, performance management, and issue resolution - Creates and manages clinical trial budgets and staffing/resourcing plans - Provides study-specific direction and mentoring to Clinical Site Managers, Clinical Trial Associates and support staff as appropriate - Provides support and mentoring to other Clinical Trial Managers - Ensures trial adherence to ICH/GCP/local regulations - Participates in clinical operations initiatives and programs as assigned Competencies Identified for Success: - Highly developed leadership skills to build and directs the Protocol Execution Team to ensure that timeline, cost and quality metrics are met - Effective written and verbal communication skills - Extensive experience developing trial plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management - Extensive clinical research knowledge and cross-functional understanding of clinical trial methodology - Collaborates effectively with the Clinical Operations study team, cross-functional team members, and external partners Education, Experience
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Job Requirements:
6343381
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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