Global Study Manager

Vaga não está no LinkedIn

🕒 Maio 2

🌐 Estados Unidos, Canadá – Remoto

🇺🇸 Estados Unidos – Remoto (EUA) 🇨🇦 Canadá – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👔 Gerente

👻 Score fantasma 55%

O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

ICON plc

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1990

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A ICON plc é uma provedora global de serviços clínicos, de consultoria e comerciais que atendem a diversos setores das indústrias de saúde e farmacêutica. A empresa oferece uma ampla gama de soluções clínicas, incluindo ensaios clínicos descentralizados, soluções de segurança cardíaca, laboratórios clínicos de fases iniciais e imagem médica. A ICON também fornece soluções de tecnologia que apoiam o desenvolvimento de medicamentos desde as fases iniciais até o pós-comercialização. Sua expertise terapêutica abrange cardiovascular, oncologia, medicina interna e mais, com forte foco em terapias transformadoras, como terapias celulares e gênicas e biossimilares. Reconhecida como uma das principais CROs (Contract Research Organisations), a ICON oferece regularmente thought leadership e contribui para publicações e eventos do setor. Seus serviços são personalizados para otimizar ensaios clínicos, fornecer inteligência regulatória e gerar evidências do mundo real por meio de análise de dados robusta e soluções centradas no paciente.

Descrição

• Provide operational leadership across the full clinical study lifecycle • Lead global clinical trials from sourcing strategy and RFP development through study start-up, execution, database release, and inspection readiness • Represent the operational function on the core study team • Drive recruitment strategies and milestone delivery • Lead and coordinate internal teams, external partners, and vendors • Oversee study-level plans, performance metrics, vendor scope, budgets, and risk mitigation • Form, oversee, and lead the operational sub team and request resources • Develop study startup, study management, monitoring, sourcing, recruitment, and related plans • Coordinate protocol training and global investigator meetings • Oversee country-level feasibility, site approval, and site activation plans • Manage study management and country/site-level documents and risk planning inputs • Develop clinical trial budget inputs and monitor vendor budgets, contracts, expenses, invoices, purchase orders, and forecasts • Ensure delivery of the study against approved plans • Lead inspection readiness and site readiness activities • Support decentralized capabilities at investigator sites • Ensure timely study closure and release of resources after database lock • Oversee drug supply management and interactive randomization system setup • Review feasibility outputs and pre-trial assessment reports • Support study-level submission readiness and vendor UAT/system setup reviews • Ensure applicable system closure at study completion • Oversee study startup and monitoring functions for SOP and quality compliance • Coordinate with data management and review data reports and dashboards to identify risks • Escalate plan deviations and oversee mitigations • Assess enrollment and discontinuations for financial forecasting • Provide operational input into protocol design • Lead protocol deviation trend reviews and vendor calls • Serve as technical expert for study management systems and processes • Champion harmonized processes and high-quality, cost-effective clinical trial data • Provide technical oversight, performance feedback, metrics review, and issue escalation/resolution • Partner with operational teams and pCROs to resolve performance issues • Support audits and inspections

🎯 Requisitos

• Working knowledge of Good Clinical Practices, monitoring, clinical and regulatory operations • A scientific or technical degree is preferred along with extensive knowledge of clinical trial methodology • BA/BS 7+ years of relevant experience • MBA/MS/ 6+ years of relevant experience • Demonstrated clinical research experience and/or study management experience • Demonstrated study management/leadership experience • Demonstrated oversight of CROs/vendors • Demonstrated experience in managing per subject costs, vendor & ancillary, and monitoring costs projections & spend • Exceptional knowledge of own discipline and advanced knowledge of others • Ability to develop ideas and lead complex projects • Ability to develop innovative solutions to complex problems • Ability to work independently with assignments often self-initiated • Legal right to work in the country where the role is based

🏖️ Benefícios

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways