Clinical Trial Manager, FSP

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

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.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.

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Manage clinical operational and quality aspects of allocated low- to moderate-complexity studies in compliance with ICH GCP • Develop clinical tools, monitoring plans, monitoring guidelines, and data quality plans • Contribute to Master Action Plans and maintain relevant Trial Master File sections • Participate in designing CRFs, CRF guidelines, informed consent templates, and protocol-specific documents • Collaborate with project managers to prepare and present client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and departments to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Archive study documents and materials • Prepare and monitor clinical activity timelines and metrics • Provide project status updates, review tracking tools, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Monitor or co-monitor clinical trials and assess performance against contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions • Communicate with study sites about protocols, patient participation, case report forms, and study issues • Coordinate study start-up activities and ethics committee and regulatory submissions • Ensure essential document quality and follow up on ethics committee questions • Contribute to clinical activity forecasts • Manage clinical resources, delegate responsibilities, and identify additional resource requirements

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Combination of appropriate education, training and/or directly related experience may be considered equivalent • Good leadership, mentoring, training, motivation, and team-integration skills • Good planning and organizational skills • Solid interpersonal and problem-solving skills • Ability to work effectively in changing environments with complex/ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budget and adjust resources • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Good computer skills, including Outlook, Excel, Word, and computerized applications • Frequent domestic and international travel • Frequently drives to site locations

🏖️ Benefícios

• Global team environment • Collaboration and development opportunities • Exposure to passion, innovation, and scientific excellence • Standard Monday–Friday work schedule

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