Manager

• Planning, management, and oversight of clinical study execution in accordance with the global program strategy, through leadership of the Local Study Team (LST)
• Supports country-level operational planning and accountable for site selection within assigned country/countries
• Contributes and develops study-specific materials – e.g., monitoring plan, study specific training documents
• Supports and contributes to Clinical Study Teams (CSTs) / Trial Management Teams (TMTs) as applicable, agenda-driven, present at meetings
• Communicates country status (including timelines and deliverables) to key stakeholders (e.g., Global Clinical Managers [GCM], Program Managers, CST or TMT, Development Operations Manager [DOM] etc) with oversight as required and ensures updates to relevant systems
• Accountable for site-level goals setting and study-specific deliverables for clinical sites within their country/countries
• Contributes to the study-level forecast for investigational product, study level accountability and reconciliation across assigned countries, management of ELE ( enrolment long-range estimates) process
• Monitors the execution of the clinical study against timelines, deliverables, and budget for that country
• Translates global start-up requirements into local country targets
• Monitors country enrolment and retention and act on deviations from plan
• Identify barriers to enrolment and support recruitment and retention strategic solutions
• Monitors and acts upon data flow metrics - review, trend identification and analysis
• Monitors and reviews country and study trends
• Reviews Monitoring Visit Reports
• Identifies and facilitates resolution of cross-functional study-specific issues
• Provides updates regarding the study budget and obtains approval for budget deviations for clinical sites (outside of range)
• Escalates any issues related to delivery, timelines, or budget to GCMs (or TMT lead if appropriate)
• Escalates CRA performance issues to applicable Clinical Trial Oversight Manager
• Conducts on-site quality visits with CRAs where/when appropriate and supports the maintenance of site relationships

Local Trial Manager - US Remote

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