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Clinical Study Manager

Company: Aerotek
Location: Raleigh
Posted on: October 20, 2019

Job Description:

Scope of Project: -- Lead the start-up, execution, and closeout of multiple studies (US or overseas) Lead or contribute to integrated clinical study team meetings to ensure high scientific, ethical and regulatory standards, and expeditious registration submissions worldwide Works efficiently with internal regulatory, CMC, and clinical trial supplies, project management, and quality personnel to seamlessly meet key study milestones -- -- -- -- Constructs or reviews study plans and documents (e.g. protocols, Informed Consent Forms, CRFs, Monitoring Plan and associated tools, Patient Information Sheets) and coordinate translations as needed -- -- -- -- Oversee study related site management and monitoring activities -- -- -- -- Manage --and help select study vendors including Phase 1 units and bioanalytical laboratories, statistical support and case report forms/data management services -- -- -- -- Contributes to or provides proactive solutions to study-related issues -- Experience Desired: -- Minimum of 5 years study management responsibility including site/CRA management. BS degree required -- -- -- -- Experience in vendor management required. Must be able to work independently, adapt to changing priorities, with the ability to take initiative to complete tasks accurately and timelines

Keywords: Aerotek, Fayetteville , Clinical Study Manager, Healthcare , Raleigh, North Carolina

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