Site Augmentation Lead

🔥 21 minutes ago

🇧🇷 Brazil – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• 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.

🎯 Requirements

• 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.