Manager, Monitoring – Site Management

🕒 Outubro 5

🌲 North Carolina, Massachusetts, +3 estados a mais – Remoto

🌲 North Carolina – Remote 🍂 Massachusetts – Remote ❄️ Minnesota – Remote 🔔 Pennsylvania – Remote 🎸 Tennessee – Remote

💵 €76.500 - €127.500 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 2%

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 38 dias.
• As vagas desta empresa costumam ser preenchidas em 51 dias.

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Alimentiv

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 2020

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

Alimentiv é uma organização de pesquisa por contrato (CRO) especializada, focada em doenças gastrointestinais (GI) e hepáticas. Com mais de 30 anos de experiência, a Alimentiv oferece um portfólio abrangente de serviços de pesquisa clínica e de imagem, incluindo gestão de ensaios clínicos, gestão de centros (sites), assuntos regulatórios e medicina de precisão. A empresa está na vanguarda da pesquisa e desenvolvimento médicos, fornecendo soluções de imagem de última geração e insights acionáveis de biomarcadores. A Alimentiv apoia o desenvolvimento de compostos para GI e atua em mais de 60 países, trabalhando com uma rede de especialistas médicos e operacionais para acelerar ensaios clínicos e o recrutamento de pacientes.

Descrição

• Plan, manage, organize, evaluate, and/or report on day-to-day delivery of the Clinical Monitoring unit • Develop and improve policies and processes • Monitor product quality, sites, and compliance • Plan staff resources and manage staff and contractor performance • Support, provide expertise to, and represent project and clinical monitoring teams with sponsors and researchers throughout the project life cycle • Ensure team members and third-party providers deliver high-quality, timely services in accordance with corporate and industry best practices and regulatory requirements • Identify, develop, plan, monitor, approve, and/or report on project-specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, global project harmonization, SOP and QS document maintenance, periodic site visits, and IT collaboration • Represent and support Clinical Monitoring teams with internal partners and external sponsors to identify improvements, address concerns, and integrate new technologies and processes • Manage Clinical Monitoring team staffing, work allocation, resource planning, training and development, technology, process development, expense management, employee engagement, and performance management • Identify, procure, and manage Clinical Monitoring independent contractor services, including needs assessment, recruitment, contract negotiations, policy compliance, training, cost monitoring, and performance management • Develop tools supporting project teams and business development in clinical, site, and compliance monitoring from bidding through reporting findings to sponsors

🎯 Requisitos

• College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred), or SoCRA and/or ACRP Certification/Designation • Minimum of 4–6 years of related experience plus substantial ongoing training • Experience managing CRA staff • Ability to provide training and/or mentorship to colleagues on a 1:1 basis or in meetings • Ability to work in a remote global capacity • Strong knowledge of regulations and guidelines pertaining to clinical monitoring and GCP • Customer service-oriented and solution-oriented approach • Demonstrated leadership skills • Strong verbal, written, and organizational skills • Ability to handle multiple tasks and meet deadlines in a dynamic environment

🏖️ Benefícios

• Bonus • Home-based/remote work

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