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Manager , Project Managment Job
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| Employer Name: BiotechCrossing |
SpiderID: 2366525 |
| Location: Fremont, California |
Date Posted: 7/14/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6281456 |
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Job Description:
Responsible for ensuring the trial is “audit ready” at all times (project team training records, central files, system validation, etc.).Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.Responsible for effective communication within the Clinical Project Team and with functional management.Provide regularly updates regarding the status and progress of the trials (Therapeutic Lead, Business Alliance, etc.)Manage the project(s) within the approved budgets and timelines.Responsible for writing of clinical project deliverables such as protocol, final study report, study manuals, study tools, operational plans, etc. within the CPP framework.Prepare investigational site lists and participate in reviewing and approving investigational sites. Direct forecasting of devices necessary for project in collaboration with supply-chain; review and approve various support system specifications.Support the coordination and attend investigator and coordinator meetings, representing the clinical project team.Provide oversight of individual clinical trials to ensure that safety concerns and/or adverse events are identified and appropriate responses to such concerns are developed and executed.Responsible for the identification of project risks and the development and implementation of the mitigations for these risks.Prepare and present the status of the clinical project(s) to the Clinical Management Board.Represent Clinical on PDP core teams (with or without a clinical trial).Provide updates to the PDP core teams about the product risk documents (CRBA, FMEA, etc.)
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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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