Regional Study Manager I Job

Employer Name: BiotechCrossing	SpiderID: 2214608
Location: Collegeville, Pennsylvania	Date Posted: 5/6/2008
Wage:	Category: Biotech
Job Code:

Job Description:

Ensure regulatory compliance & 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 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 Management. Assist (GTL) with Investigator Meeting preparation relative to regional considerations / separate regional meetings when applicable Assist GTL in creating operational training materials specific to a region. Liaise with Study Team colleagues, CTAs, and Operations Specialist groups as necessary. Coordinate with Drug Supply to track and manage regional site supply Report site enrollment activities.Primary reviewer of trip reports. Ensure completeness of trip report Proactively 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 needed Assists Site Manager with issue escalation and resolution of open issues.

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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

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com