Site Augmentation Lead

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Act as the main point of contact for sponsor clients, sites, and Illingworth business units regarding assigned Site Augmentation projects.

• Supervise assigned Site Augmentation projects from handover to completion and final closeout.

• Collaborate with Resource Management, Finance, IT, Associate Director Site Solutions, and Director SO&E to ensure project delivery and resolve any issues.

• Organize project-specific training needs and delivery for deployed site resources.

• Lead the creation, review, and finalization of project documentation in accordance with policies, SOPs, ICH-GCP, and regulatory standards.

• Oversee project budgets, financial forecasts, monthly invoices, reconciliations, scope modifications, and change orders.

• Execute projects while adhering to established timelines, quality standards, implementation plans, and performance metrics.

• Maintain project trackers and business continuity documentation.

• Cultivate site relationships, develop site optimization strategies, and manage site engagement and contracting processes.

• Direct site augmentation resource management, including resource requests, recruitment, allocation, onboarding, and deployment oversight.

• Serve as the company representative for site and sponsor clients both internally and externally.

• Assist with Site Augmentation initiatives, information libraries, communication materials, RFI/RFP development, and client inquiries.

• Ensure that deliverables, projections, reports, updates, risk assessments, and mitigation strategies align with customer expectations.

• Convert protocol requirements into suggested site solutions in collaboration with sponsors and cross-functional leaders.

⛳️ Requirements

• Equivalent experience, skills, and/or education will be taken into account.

• Capability to manage clinical research site augmentation projects through to completion.

• Familiarity with clinical SOPs, ICH-GCP, and relevant country regulatory requirements.

• Proficiency in managing project budgets, forecasts, invoices, reconciliations, scope changes, and change orders.

• Ability to create, review, and finalize project documentation effectively.

• Skill in coordinating project-specific training for site resources.

• Competence in managing site resource recruitment, allocation, onboarding, and training processes.

• Ability to translate protocol requirements into effective site solutions.

• Capability to work collaboratively with sponsors, CROs, clinical trial sites, vendors, and cross-functional teams.

• Proficiency in overseeing performance, issue management, quality compliance, risk assessment, and mitigation strategies.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• Competitive compensation package.