Clinical Team Manager

🕒 4 dias atrás

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 15%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 4 dias.
• As vagas desta empresa costumam ser preenchidas em 22 dias.
• Sem salário divulgado.

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ERGOMED

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 1997

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

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

• Manage assigned clinical teams, including CRAs • Develop, review, and revise clinical trial documents, including Clinical Monitoring Plans • Support project managers with study KPIs, timelines, budgets, invoicing, and staff time approval • Contribute to clinical risk management and Critical to Quality Factors and Quality Tolerance Limits • Recommend investigators and sites and review and approve PSV reports • Oversee site initiations, supply management, site activation documentation, CRA assignments, and site visit schedules • Organize internal project team meetings and provide study status and protocol deviation updates • Support setup and maintenance of trial master files and oversee ongoing and final quality control • Review CRA site visit reports and ensure timely, high-quality completion • Manage investigational product and study supplies • Review data listings and query reports, identify trends, and implement mitigation or retraining actions • Oversee protocol deviation and study non-compliance documentation, tracking, escalation, and corrective/preventive actions • Act as site contact when CRAs are unavailable and escalate unresolved issues to project management • Oversee clinical staff tasks, including CRA travel approvals • Manage trial close-out activities • Communicate and collaborate with sponsors, investigators, partners, and cross-functional teams • Support patient recruitment and retention plans • Coordinate preparation for site audits and inspections and oversee corrective and preventive action plans • Mentor and train new staff and conduct Monitoring Evaluation Visits • Oversee contracting or invoicing of local clinical vendors • Develop and revise SOPs in accordance with Good Clinical Practices and regulatory requirements • Participate in bid defense meetings and company process improvement initiatives • Perform monitoring activities as needed based on project needs

🎯 Requisitos

• Degree or RN degree in a life science or other related field, or equivalent education and experience • Minimum of 6 years of clinical research experience in multiple studies and countries • Experience managing the clinical part of studies in more than one region or equivalent study complexities • Ability to mentor and train other CTMs and CRAs in a positive and effective manner • In-depth knowledge of clinical trials and the critical elements for success in clinical trials • Diverse therapeutic area expertise and skills

🏖️ Benefícios

• Collaborative, international team environment • Career growth opportunities • Flexible work environment • Work-life balance • Passionate and collaborative team of experts • Opportunity to help bring safe and effective pharmaceutical treatments to patients worldwide

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