Regional Study Manager Job

Employer Name: PharmaceuticalCrossing	SpiderID: 2359092
Location: Collegeville, Pennsylvania	Date Posted: 7/10/2008
Wage:	Category: Medical/Health
Job Code: 6289789

Job Description:
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 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 Global Trial Leader (GTL) with Investigator Meeting preparation relative 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 Provide local input to site selection committees Conduct site feasibility Accountable for enrollment across the region.

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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: PharmaceuticalCrossing

City: Pasadena
State: California
Zip:

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