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Clinical Project Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2208221 |
| Location: Waltham, Massachusetts |
Date Posted: 4/29/2008 |
| Wage: |
Category: Biotech |
| Job Code: |
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Job Description:
This position will develop and implement initiatives aimed to ensure the successful and timely completion of the Phase IIB clinical trials and all related clinical trial milestones, and those of other products of the Company. The lead product, represents a promising new treatment for DIC (disseminated intravascular coagulation) in sepsis.Responsibilities:- Provide input on the clinical study design, monitor trial progress, manage the project level budget and oversee quality assurance, managing external vendors, data management, and ensuring that reporting activities are completed. - Direct site communication and clinical monitoring input related to product development; - Oversee vendor training for all clinical aspects of drug development; - Coordinate materials for clinical trials; - Validate site-specific regulatory documents for IND and BLA filing; - Track tasks performed by CRAs and independent contractors; - Monitor vendor GCP audits- Review all clinical documents. - The CPM will have responsibility for reviewing, and creating Clinical Monitoring SOPs, managing training, and providing a leadership role in the maintenance of Clinical Operations Monitoring standards.
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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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