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Posted on : 02 June 2017

Project Description

AutoReqId 33702 Title ASSOCIATE, SITE ACTIVATION MANAGEMENT (SAM) - Ukraine, Kiev State / Province 852 Country #:@08=0 Position Location  538>=0;L=K9 >D8A /  >D8A5 Company Overview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esponsibilities Ukraine, KievPurpose: The mission of the Site Activation Management (SAM) is to provide regulatory expertise to customers through ownership of site activation, focus and alignment on the objectives and priorities of the Business Units, and exceptional communication. In carrying out this responsibility, the SAM Associate will be responsible of the site activation of clinical investigator sites, negotiation and processing of regulatory and applicable operational documents to ensure ER ready, as well as the management of all applicable regulatory and operational aspects of ongoing study conduct. SAM Associatewill provide operational expertise to Regulatory Agencies (MOH) and Central/Independent/Site's Ethical Review Boards (ERB) activities. SAM Associatewill be the main contact with MOH/ERB/other applicable entities and will provide technical and operational expertise for study feasibility, site evaluation process, submissions and inspections. SAM Associatewill ensure effectively support to Clinical Operations team like site activation activities through study initiation to study closure. SAM Associatewill ensure that essential clinical study documentation within country of responsibility is managed in compliance with Good Clinical Practices (GCP) and appropriate Quality Standards and Procedures. Key Responsibilities: Regulatory delivery/Relationship


Киев, Украина

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