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| Employer Name: BiotechCrossing |
SpiderID: 2369214 |
| Location: Cambridge, Massachusetts |
Date Posted: 7/15/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6314588 |
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Job Description:
The Study File Manager II will represent the Study File Management group at Study Team and CRO study start-up and on-going meetings. Job ResponsibilitiesThe Study File Manager II will perform these and other responsibilities depending on the support needs of the department and the rector (CTD), Global Trial Leader (GTL) RSM, Clinical Scientist, Medical Monitor and supervisors 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. 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.
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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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