Regional Project Lead

🕒 4 dias atrás

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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

• Plan, implement, and manage clinical research 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 report progress when delegated by the Project Manager • Collect and report project status updates for designated regions internally and externally • Develop and update project planning documents, essential study documents, and project manuals/instructions • Manage and report KPIs for designated countries and clinical project team members • Ensure project timelines and subject enrollment targets are met in designated countries • Coordinate study-specific and corporate tracking systems • Coordinate site contractual startup and budget negotiations • Establish project-team communication lines and supervise clinical project team members’ performance • Identify, escalate, and resolve resourcing and performance issues • Conduct or supervise therapeutic-area training of project teams when delegated • Prepare presentations and conduct Investigator training • Ensure team compliance with project-specific training matrices • Conduct field training of Monitors tailored to project needs • 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 study audits/inspections and resolution of findings • Coordinate supervised monitoring visits • Review site visit reports and ensure monitoring and 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 and approve project-related expenses and timesheets when delegated by the Project Manager

🎯 Requisitos

• College/University degree in Life Sciences or equivalent combination of education, training, and experience required • Prior experience in Clinical Research and independent on-site monitoring required • Experience as a Study Manager/Clinical Trial Manager with ability to supervise project activities as a Regional Lead or equivalent required • Therapeutic expertise in Oncology and/or Gastroenterology required • 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 • Must not require a work visa for employment or continued employment now or anytime in the future

🏖️ Benefícios

• Flexible working arrangements • Career growth and professional development • Opportunities to lead complex global studies • Collaborative, people-first culture • Stable organization where long-term careers are built • Meaningful work that helps bring innovative therapies to patients around the world