Regional Study Manager I Job

Employer Name: BiotechCrossing	SpiderID: 2211377
Location: Collegeville, Pennsylvania	Date Posted: 5/2/2008
Wage:	Category: Biotech
Job Code:

Job Description:

Conduct site feasibility Accountable for enrollment across the region.Must take a proactive approach to site planning across the region Accountable and responsible for tracking enrollment across the region Provides regional input to protocol, CRF design and operational aspects of the entire study Accountable for collaboration with Site Managers to complete Site Qualification Visit (SQV) Conduct site set up and work with operational specialists to complete all tasks. Ensure protocol training of Site Managers and support for region, as applicable. Provide drug supplies in accordance with import / export rules and regulatory approval Verify sites have received all study materials and are prepared for study initiation visits (SIVs) Work with Site managers to drive timely completion of SIVs Set up logistics for region Identify local vendors Ensure contracts are set up and signed Ensure appropriate payments are made to sites and local vendors. Accountable for ensuring high-quality data entered into the system and delivered on time for the region. Compare site information across the region to ensure consistency and recognize regional issues not apparent at a single site. Review missing data reports and open query reports for region. Work with Site Managers to drive data retrieval in region to support database deliverables. Liaise with regulatory organizations. Interact with IRB for study start and safety communications. Interact with central EC/IRB if applicable within the region Manage site regional regulatory issues Correspond with local ethics committees.

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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