Regional Study Manager Job

Employer Name: BiotechCrossing	SpiderID: 2298678
Location: Collegeville, Pennsylvania	Date Posted: 6/20/2008
Wage:	Category: Biotech
Job Code: 5393277

Job Description:

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.II. JOB RESPONSIBILITIES -1. Accountable for regional study execution 25% Drive site-level timelines across the region Provide input and approve region specific portions of the monitoring plan aswritten by the GTLo Ensure execution of monitoring plan in region 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 tofilter 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 input2. Act as a secondary point of contact (Site Manager is the first) and point of escalation for 15%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 region3. Represent regional Site Management on study team 20% Serve as the communications conduit between the study team and the site andRegional Site Management Assist Global Trial Leader (GTL) with Investigator Meeting preparation relativeRegional 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 asnecessary Coordinate with Drug Supply to track and manage regional site supply Report site enrollment activities.

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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: 91101

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