Specialist, Country Study Start Up

The 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 responsibilities • Ensure 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.  • Maintain SSU performance metrics and key performance indicators (KPIs) for assigned sites/studies.   • Provide start up updates and metrics to CCOM/COM and Area SSU and CSM Leads • Ensure audit/inspection readiness. • Ensure compliance with corporate and divisional policies and procedures in alignment with worldwide regulations and guidelines. • Drive to improve site start-up efficiency, which includes leading process improvement initiatives.  • Function as an SME in the SSU community and leads training and mentoring of Country Start Up Specialists, drive change management in the adoption of new technologies and processes. • Act as an area lead for studies that only involve one country (i.e.: the US only trials). Experience / Education required • Bachelor's degree in Health Care or Science highly preferred. • A minimum of three years of clinical research experience and preferably more than two years of study start up management experience for the designated region. • Must have hands on experience in interpreting regional clinical research regulations and processes. • Experience working with central and local IRB/EC sites, inclusive of reviewing site and IRB/EC comments on ICFs and routing for approval by required functional areas. • Adept and experienced working with Vault SSU in the capacity of essential docume