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Regional Study Manager Job
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| Employer Name: BiotechCrossing |
SpiderID: 2388293 |
| Location: Collegeville, Pennsylvania |
Date Posted: 7/23/2008 |
| Wage: |
Category: Biotech |
| Job Code: 6648494 |
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Job Description:
QuestionsAccountable for Investigator Relationship Management for region. Represent regional Site Management on study team Serve as the communications conduit between the study team and the site and regional Site ManagementAssist Global Trial Leader (GTL) with Investigator Meeting preparation relative regional considerations / separate regional meetings when applicableAssist GTL in creating operational training materials specific to a regionLiaise with Study Team colleagues, CTAs, and Operations Specialist groups as necessaryCoordinate with Drug Supply to track and manage regional site supplyReport site enrollment activities. Primary reviewer of trip reports Ensure completeness of trip reportProactively address all operational issues that the site manager is unable to resolve by liaising with the appropriate study team member, global service, or other individual as neededAssists Site Manager with issue escalation and resolution of open issues. Provide local input to site selection committees Conduct site feasibilityAccountable for enrollment across the regionMust take a proactive approach to site planning across the regionAccountable and responsible for tracking enrollment across the regionProvides regional input to protocol, CRF design and operational aspects of the entire studyAccountable for collaboration with Site Manager to complete Site Qualification Visit (SQV). Conduct site set up and work with operational specialists (OS) to complete all tasks Ensure protocol training of Site Managers and support for region, as applicableProvide drug supplies in accordance with import / export rules and regulatory approvalSupport Site Manager relative SIVAlso, verify sites have received all study materials and are prepared for SIVSet up logistics for regionIdentify vendorsEnsure contracts are set up and signed. Accountable for ensuring high-quality data entered into the system and delivered on time for the region.
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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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| Zip: |
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Web Site: http://www.biotechcrossing.com
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