Clinical Regional Project Lead

🕒 Agosto 4

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PSI CRO AG

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1996

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

PSI CRO AG é uma organização global de pesquisa por contrato (CRO) especializada na condução de ensaios clínicos. A empresa foca na entrega de ensaios clínicos pivotais de Fase 2 e Fase 3 em diversas áreas terapêuticas, incluindo Doenças Inflamatórias Intestinais, Oncologia, Hematologia, Doenças Infecciosas, Esclerose Múltipla e Doenças Raras. A PSI utiliza uma plataforma tecnológica proprietária para planejamento de ensaios clínicos e controle financeiro, garantindo que os estudos sejam conduzidos no prazo e dentro do orçamento. A empresa é reconhecida por sua expertise, qualidade, compatibilidade e confiabilidade, tendo sido premiada no CRO Leadership Awards por vários anos consecutivos.

Descrição

• Oversee, manage, and coordinate clinical trial project-team activities in designated countries and ensure consistency of Clinical Operations processes across regions • Ensure study milestones, timelines, and subject-enrollment targets are met at country and regional levels • Plan, implement, and manage projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents • Act as primary or secondary project-management contact for project teams and PSI support services in designated countries • Review study status and provide progress reporting • Collect and report project-status updates internally and externally • Develop and update project-planning documents, essential study documents, and project manuals/instructions • Manage and report Key Performance Indicators for designated countries and clinical project-team members • Coordinate study-specific and corporate tracking systems • Coordinate site contractual startup and budget negotiations • Establish project-team communication lines and supervise clinical project-team performance • Identify, escalate, and resolve resourcing and performance issues • Conduct or supervise therapeutic-area training and Investigator training • Ensure compliance with project-specific training matrices • Provide field training to Monitors • Supervise site selection, site initiation, routine monitoring, and closeout visits • Oversee investigator and site payments, CRF data retrieval/upload, monitoring, and query resolution • Supervise project-team preparation for audits/inspections and resolution of findings • Coordinate supervised monitoring visits • Review site visit reports and ensure monitoring/reporting standards are met • Coordinate initial and follow-up Regulatory and Ethics Committee submissions and notifications • Oversee safety-information flow and participate in feasibility research • Review/approve project-related expenses and timesheets when delegated by the Project Manager

🎯 Requisitos

• College/University degree in Life Sciences or an equivalent combination of education, training & experience is required • Prior experience in Clinical Research and on-site monitoring is required • Prior experience monitoring within the US • Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent is required • Experience in Oncology is required • Experience in GI is preferred • Full working proficiency in English • Proficiency in MS Office applications, including MS Project • Communication, presentation, and customer-service skills • Ability to negotiate and build relationships at all levels • Team-building, leadership, and organizational skills

🏖️ Benefícios

• Remote work option • Hands-on involvement in every aspect of the study • Career growth opportunities • Work with a company that puts its people first