Site Augmentation Lead
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Job Description
Site Augmentation Lead overseeing clinical research site augmentation projects for pharmaceutical, healthcare, biotechnology, and medical device clients. Managing resources, budgets, regulatory compliance, site relationships, and project delivery.
Responsibilities:
- 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.
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