Sanofi Aventis Work Values

Daily Duties at Sanofi Aventis:

• Support project teams to ensure successful completion of the clinical trial in accordance with ICH/GCP guidelines, current Federal regulations, and SOPs by communicating and providing assistance to site and Clinical Research Associates as needed. • Assist Clinical Project Leader and Clinical Research Associates with the creation of regulatory document submission and initiation packages. • Coordinate with the clinical project team for the distribution, retrieval, and review of regulatory documents throughout all phases of a clinical trial. • Tracking and scanning of regulatory documents for FDA submission. • Maintain all clinical trial monitoring systems and databases including Microsoft Access and Excel, IMPACT, Catalyst financial system, Oracle Identity Manager, and IVRS systems. • Responsible for distribution of mass mailings and shipping supplies to sites and Clinical Research Associates. • Ensure accuracy of required regulatory documents throughout the clinical trial. • Communicates and provides assistance to sites and project team as needed. • Utilize IVRS systems and Microsoft Excel to manage investigational product shipping requests. • Request Clinical Grant payments using Access and Catalyst as per the Clinical Trial Agreements and Amendments. • Request Clinical Trial Agreement Amendments by collaborating with the Legal and Finance Departments and investigator sites. • Audit local and general study files periodically throughout the course of the trial in preparation for audit readiness and close-out visits by ensuring accuracy of required regulatory documents. • Collaborate with corporate colleagues and Clinical Research Associates in preparation for database lock and ensuring all study files are archived appropriately per SOPs after database lock.

What they like about Sanofi Aventis:

Organizations with strong, centralized leadership are particularly attractive to you. You require a work environment with leadership that aggressively seeks to expand and grow the business and does so in a visible and decisive manner. In general you prefer to work in an environment in which there is a strong link between leadership, its actions, and a strong set of company-wide values.

Tags

clinical project assistant

Skills

Microsoft Word, Excel, and Access., IMPACT database, Oracle Identity Manager for eCRF studies, IVRS (Interactive Voice Response Systems) for investigational product., Catalyst Financial System, ARISg safety database.

These are some of the questions we asked our climbers about their experiences with Sanofi Aventis: