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| Employer Name: BiotechCrossing |
SpiderID: 2357566 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/10/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6314588 |
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Job Description:
MA)Job SummaryThe Study File Manager II is responsible for managing, training, and evaluating the team, which is comprised of, the Senior Study File Analyst, Study File Analyst and Document Coordinator in their location, as well as supporting management in identifying and resolving issues regarding regulatory documentation process and procedures in support of clinical trials for their assigned therapeutic area(s). The Study File Manager II will collaborate with Study File Management and the Regional Study Manager (RSM) to ensure clinical trial regulatory documentation is managed in accordance with Good Clinical Practice (GCP), regulatory requirements and Wyeth SOPs. The Study File Manager II is a knowledgeable resource and supports individual staff member’s growth and development into positions of greater responsibility. The Study File Manager II will represent the Study File Management group at Study Team and CRO study start-up and on-going meetings.on of final study documents in EDMS. Manage collaboration with the Study Team, Compliance, Investigative Sites, Regions, and Vendors to determine resolution to issues in regulatory documentation. Manage team’s work productivity and track developmental progress. Responsible for managing Clinical Research Organization’s performance of regulatory document collection. Manage quality review on documents submitted to Records Management. Oversee team to ensure documents are submitted with complete and accurate content per equirements. Notify supervisor of any recurring inconsistencies to ensure corrective actions with department heads. Responsible for managing statuses of documents in the E-clinical tracking application. Manage and provide therapeutic area expertise in clinical trials, in collaboration with the RSM and Medical Research. Manage quality control of documents reviewed and processed by the team. Assist in process improvements for the therapeutic area and implement these changes in conjunction with Management.or a fee to be paid for any candidate referrals.
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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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