25 ene
Abbvie
Xico
.Company DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
For more information about AbbVie, please visit us at www.Abbvie.Com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.Job DescriptionThe Specialist,
Country Study Start Up proactively drives and executes all start-up and maintenance-related activities and deliverables for assigned studies and sites in their assigned country or countries.
For studies that only involve one country, the Specialist, Country Study Start Up is responsible and accountable for one time, budget and quality delivery and execution of the start-up and maintenance activities (i.E.
: the United States only trials).
Acts as a site start-up expert and provides Subject Matter Expert (SME) support.Key responsibilitiesEnsure successful and on time and quality execution of start-up and maintenance activities for assigned sites and studies; site assignment scope inclusive of central and local Institutional Review Board (IRB)/ Ethics Committee (EC) sites.Establish the country/site activation plans and priorities including risk assessment and mitigation plans with Country Clinical Operations Manager (CCOM) / Clinical Operations Manager (COM), ASUL and Clinical Site Management (CSM) Lead, Contract Manager, Contract Management Specialist (CMS)
/Regulatory Affairs.Proactively identify and communicate issues impacting delivery and providing proposed solutions.Attend regional/area start up calls and providing input for assigned sites/studies.Collect essential documents from sites and completing quality check Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).Compile and submit ethics and other required local submissions including customization of Informed Consent Forms (ICFs), patient facing materials and safety reporting.Coordinate with Regulatory and CMS on Competent Authorities (CA) submission and approval status to assure alignment with other site activation requirements.Collaborate with contract manager, Clinical Research Associate (CRA), Area CSM Lead as required to assure timely site activation.Review site and IRB/EC comments on ICFs and routing for approval by required functional areas.Facilitate clinical supply shipments.Complete Investigational Product (IP)
release activities and triggering IP shipment.Issue site green light letter and activating sites in Interactive Voice/Web Response System (IXRS).Track all start-ups and maintenance-related activities in Vault Study Start-Up (SSU) as appropriate.Maintain local country and site intelligence database and Expected Document Lists (EDLs) in Vault
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