O SEU PRÓXIMO CAPÍTULO
Site Augmentation Lead
Sobre a vaga
• Serve as the primary point of contact for sponsor clients, sites, and Illingworth business units for allocated Site Augmentation projects.
• Oversee allocated Site Augmentation projects from handover through completion and closeout.
• Liaise with Resource Management, Finance, IT, Associate Director Site Solutions, and Director SO&E for project delivery and issue resolution.
• Coordinate project-specific training requirements and delivery for deployed site resources.
• Lead development, review, and finalization of project documentation in compliance with policies, SOPs, ICH-GCP, and regulatory requirements.
• Manage project budgets, financial and activity forecasts, monthly invoices, reconciliations, scope changes, and change orders.
• Deliver projects according to agreed timelines, quality standards, implementation plans, and performance metrics.
• Maintain project trackers and business continuity information.
• Develop site relationships, site optimization strategies, and site engagement and contracting processes.
• Lead site augmentation resource management, including requesting resources, recruitment, allocation, onboarding, and deployment oversight.
• Act as company champion for site and sponsor clients internally and externally.
• Support Site Augmentation initiatives, information libraries, communication materials, RFI/RFP development, and client queries.
• Ensure deliverables, projections, reports, updates, risk assessments, and mitigation strategies meet customer expectations.
• Translate protocol requirements into proposed site solutions with sponsors and cross-functional leads.
• Equivalent experience, skills, and/or education will be considered.
• Ability to manage clinical research site augmentation projects through completion.
• Knowledge of clinical SOPs, ICH-GCP, and applicable country regulatory requirements.
• Ability to manage project budgets, forecasts, invoices, reconciliations, scope changes, and change orders.
• Ability to develop, review, and finalize project documentation.
• Ability to coordinate project-specific training for site resources.
• Ability to manage site resource recruitment, allocation, onboarding, and training.
• Ability to translate protocol requirements into site solutions.
• Ability to collaborate with sponsors, CROs, clinical trial sites, vendors, and cross-functional teams.
• Ability to oversee performance, issue management, quality compliance, risk assessment, and mitigation strategies.