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Clinical Research Director Job
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| Employer Name: BiotechCrossing |
SpiderID: 2366563 |
| Location: Malvern, Pennsylvania |
Date Posted: 7/14/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6077516 |
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Job Description:
Ensure adequate reporting of adverse events, dose limiting toxicities, protocol deviations and patient status by communicating findings to appropriate sanofi-aventis staff in a timely manner. If applicable, ensure PK/PD/PG sampling and handling are performed as per protocol expectations.- Manage all in-house site related activities including maintaining regular communication with the investigator and/or their assigned contact. Responsible for financial aspects associated with the trial (i.e. CIA, budgets, payments) and ensuring regulatory submissions are performed on time. Ensure study and regulatory documentation is properly maintained in study files both at the Investigator site and at sanofi-aventis. Coordinate shipment of IP supplies to study sites. Generate other study /site specific documentation as required for the study. Set up, populate and maintain the clinical trial monitoring/management tracking system. Identify and propose solutions to operational issues with the study.- Independently monitor multiple clinical trial sites. Ensure case reports forms are accurate, complete and verifiable against source documents. Against source documents. Identify areas requiring follow up and improvement at each clinical study site and recommend corrective action. Communicate findings from contact reports and monitoring visits to appropriate sanofi-aventis staff in a timely manner.
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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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