Senior Clinical Research Director job Bridgewater New Jersey
Senior Clinical Research Director job Bridgewater New Jersey
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Senior Clinical Research Director Job

Employer Name: ClinicalresearchCrossing SpiderID: 2385596
Location: Bridgewater, New Jersey Date Posted: 7/22/2008
Wage: Category: Miscellaneous
Job Code: 6306183

Job Description:
Be capable of planning and directing a worldwide Phase II and III program involving products leading to the filing of an NDA/MAA. This entails reviewing and approving protocols and supervising the conduct of clinical studies in adherence of Sanofi-Aventis SOPs as well as institutional and governmental regulations.- Cooperate with respective functions responsible for the worldwide development of projects and to give advice regarding regulatory and tactical issues dealing with the strategy of development implementation of clinical trials in their monitoring, and their reporting for worldwide registration.- Cooperate in the building of registration dossier (ISE, ISS, etc ¦), in close relationship with Medical Writers, Data Management and Statistics.- Interact with the pharmacovigilance department to ensure that serious adverse events, involving clinical development, are followed up, evaluated, reported to regulatory authorities and notified to investigators promptly.- Ensure that all activities under his/her direction comply with Sanofi-Aventis Clinical Development Standard Operating Procedures (SOP s), Good Clinical Practices and US Regulations- Contribute expertise in and strategic contribution in Metabolism, Diabetes and Thrombosis in the conduct of clinical trials to the process at Sanofi-Aventis for competititve labels.- Represent and be a strong advocate for Clinical Development.

For more information, please click here to visit us at ClinicalresearchCrossing

For further information, please visit us online at http://www.clinicalresearchcrossing.com

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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: ClinicalresearchCrossing
City: Pasadena
State: California
Zip:
Web Site: http://www.clinicalresearchcrossing.com

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