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Regional Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2355057 |
| Location: Collegeville, Pennsylvania |
Date Posted: 7/9/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6289789 |
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Job Description:
A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job Summary The Regional Study Manager (RSM) serves as the regional project manager for a study from the time of site feasibility and selection through database lock. As part of the study team, the RSM is accountable for regional study execution and works closely with the Site Manager, CTA, and Operations Specialist to ensure quality, timely study execution and investigator support. The RSM will serve as a second point of contact for sites as backup for the Site Manager and as a point of escalation for urgent issues. The RSM will be regional Site Management representation on the study team and serve as the communications conduit between the study team and the site and regional Site Management. Job Responsibilities Accountable for regional study execution Drive site-level timelines across the region Provide input and approve region specific portions of the monitoring plan as written by the GTL Ensure execution of monitoring plan in region Ensure regulatory compliance and GCP adherence across the region Assure accurate and reconciled drug accountability across the region Maintain a strong knowledge of protocol and all medical and operational aspects to filter standard questions before reaching other disciplines within the study team Develop site level enrollment plans to achieve regional enrollment targets Accountable for site qualification and identification and selection input Act as a secondary point of contact (Site Manager is the first) and point of escalation for site when Site Manager is unavailable or unresponsive Medical Questions needing escalation to the RMM or GMM Data activities On-site tools Materials and logistics GCP Questions Accountable for Investigator.
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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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