Clinical Team Manager, Spanish Speaking

🕒 Maio 29

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

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ERGOMED

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

ERGOMED é um grupo global que oferece serviços especializados para as indústrias de biotecnologia e farmacêutica. Opera sob diferentes linhas de serviço, incluindo Ergomed Clinical Research, PrimeVigilance, e ADAMAS Consulting, e é dedicada a fornecer capacidades completas de organização de pesquisa clínica (CRO). Com foco em oncologia, doenças raras e estudos complexos, também oferece serviços completos de farmacovigilância e informações médicas, bem como auditorias abrangentes de GxP. A Ergomed está comprometida em apoiar o desenvolvimento de medicamentos com presença global em cerca de 100 países.

Descrição

• The Clinical Team Manager will be responsible for operational project management • The CTM proactively identifies, resolves/mitigates, and escalates risks and/or issues to the PM/PD and Head of Clinical Operations as necessary • Verifying and ensuring that project team members (CRAs, Site Managers, CTAs) are trained (e.g., GCP, SOP, indication, protocol, study specific procedures / requirements, etc.) to perform their assignments • Developing, reviewing and revision of project documents (e.g., monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.) • Initiating corrective / preventative measures – e.g., update of study guidance documents, performing re-training, performing co-monitoring, etc.

🎯 Requisitos

• Extensive clinical research lead experience in multiple studies • Experience in managing Clinical part of studies in more than one region or equivalent study complexities • Experience of phase 2/3 trials, ideally complex studies such as oncology or rare disease • Able to work in a fast-paced small CRO environment and manage multiple projects • A minimum of a science-based bachelor’s degree • Able to work effectively with minimal supervision

🏖️ Benefícios

• Training and career development opportunities internally • Strong emphasis on personal and professional growth • Friendly, supportive working environment • Opportunity to work with colleagues based all over the world, with English as the company language