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Study File Manager II Job
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| Employer Name: BiotechCrossing |
SpiderID: 2237335 |
| Location: Cambridge, Massachusetts |
Date Posted: 5/26/2008 |
| Wage: |
Category: Biotech |
| Job Code: 4869931 |
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Job Description:
The 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. The Study File Manager II will perform these and other responsibilities depending on the support needs of the department and the personnel in the areas supported including the Clinical Trial Director (CTD), Global Trial Leader (GTL), Regional Study Manager (RSM), Clinical Scientist, Medical Monitor and your supervisor in identifying and resolving issues regarding the study file accuracy and completeness, as required in the appropriate SOPs, regulations and study requirements. Ensure quality training for the team using appropriate training modules and monitor performance against this training, which includes, but is not limited to the following processes: - Pre-study document generation. - Coding of administrative and regulatory documents. - Utilization of the Clinical Study File Application. - Initial Test Article Release processes. - Verification of documentation in the Wyeth Official Repository. - Site communications and management of issues. - Site closeout and Inspection Readiness, including reconciliation 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 Wyeth SOPs/FDA-ICH requirements.
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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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