US-NJ: Princeton-Project Manager

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Job Title: Project Manager
Job Location: NJ: Princeton
Pay Rate: 85K-95K
Job Length: full time
Start Date: 2007-10-13

Company Name: ETS INC
Contact: Recruiting Administrator
Phone: EMAIL ONLY
Fax: 000-000-0000

Description: Responsibilities:
• Monitor study progress to assure compliance with protocol requirements, FDA regulations, Good Clinical Practices, ICH guidelines, and SOPs
• Manage Phase I/II clinical trials in North America / approx. 10% travel
• Manage local study timelines in accordance with global timelines
• Monitor and track patient enrollment and study/site progress
• Collaborate with International Clinical Trial Manager to establish a working team atmosphere
• Schedule and conduct team meetings and approve meeting minutes
• Negotiate contracts and manage budgets
• Review and approve contract CRA timesheets, vendor invoices, Investigator payments, etc.
• Review draft protocols, ICFs and CRFs
• Organize and conduct Investigators’ Meetings in collaboration with international team members
• Identify, evaluate and select investigator sites in collaboration with local Clinical Trial Team
• sue Regulatory Green Light (RGL)
• Supervise team of CRAs ensuring that the study monitors adhere to the study guidelines with regard to site management, data collection and query resolution and all protocol, CRF or other issues are resolved appropriately
• Review Monitoring Reports
• Review overall data quality issuing DCFs/resolve data queries as needed
Education/Experience:
• Bachelors degree or equivalent required; Masters degree preferred
• At least two years experience as a Project Manager in biotech/pharmaceutical industry
Knowledge/Skills:
• Ability to seek out potential problems and provide creative solutions to issues surrounding clinical operations (i.e., slow recruitment, site conflicts, etc.)
• Good communication and leadership skills
• Independent worker with ability to function in a team atmosphere
• Knowledge of all aspects of running a clinical trial for phase I-IV.
• Full knowledge of FDA regulations, ICH-GCP Guidelines, etc.

Please refer to Job code DMH-Project Man when responding to this ad.


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