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Study File Manager II Job
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| Employer Name: BiotechCrossing |
SpiderID: 2247872 |
| Location: Cambridge, Minnesota |
Date Posted: 5/31/2008 |
| Wage: |
Category: Biotech |
| Job Code: 4869931 |
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Job Description:
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. Performance management of staff. A Bachelors Degree, preferably with a life science major. Prior relevant experience with clinical research, regulatory, quality assurance (QA/QC) and/or compliance with pharmaceutical, biopharmaceutical, clinical research organizations (CRO) and/or consulting firms. A minimum of 5 years with a Bachelors Degree, or a minimum of 3 years with a Masters Degree, of that relevant experience. Experience hiring, mentoring, supervising, training and/or managing direct reports. Direct experience in management of medical/clinical study records and documentation. Knowledge of FDA regulations, Good Clinical Practices (GCP), ICH Guidelines, company SOPs, SPIs. Strong written and oral communication skills. Expertise with Microsoft Office Suite (especially Excel) and Visio.
For more information, please click here To visit us at BiotechCrossing.
For further information, please visit us online at http://www.biotechcrossing.com
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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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