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Site Management Associate I (Sma I)

Detalles de la oferta

.**Site Management Associate I (SMA I)**At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That's our vision. We're driven by it. And we need talented people who share it.If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.**Overview**The Site Management Associate I (SMA I) is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations.The responsibilities of this position include, but are not limited to: identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained.**Responsibilities**:- Completes essential document collection and review throughout the study lifecycle inclusive of site activation.- Acts as primary site contact/liaison for study and site management issues including addressing questions, inclusive of protocol questions, managing study supplies and conducting offsite central monitoring visits/contacts (pre-study, initiation, monitoring and close out visits). Escalates issues and risks as needed.- Ensure timely and complete data entry by site. Perform data review inclusive of site level data review, query resolution, facilitate database closure and freezing procedures as per study plans.- Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.- Performs all tasks in accordance with applicable guidelines, (e.G., ICH-GCP), company and sponsor SOPs, project plan, study specific processes, local regulatory requirements.- Performs a variety of routine essential document collection, review, negotiation, and maintenance and close out tasks under general supervision.- Complete submissions and notifications to regulatory authorities, ethics committee and other bodies


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

Requisitos

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