Clinical Trial Manager – FSP

🕒 6 dias atrás

🇲🇽 México – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🧪 Pesquisa Clínica

👻 Score fantasma 10%

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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 • Assume Clinical Study Manager responsibilities on small and/or less complex projects when required • Develop clinical tools, including Monitoring Plans and Monitoring Guidelines, with the Data Quality Plan • Contribute to the Master Action Plan and ensure timely setup, organization, content, and quality of Trial Master File sections • Participate in designing and developing CRFs, CRF guidelines, patient informed consent templates, and protocol-specific documents • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings • Collaborate with clinical teams and other departments to meet project deliverables • Lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train standardized clinical monitoring processes • Ensure timely archiving of documents and study materials • Achieve final clinical deliverables within contractual timelines by preparing and monitoring timelines and metrics, providing status updates, reviewing projects, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution • Monitor or co-monitor clinical trials to assess performance and meet contractual obligations • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocol, patient participation, case report forms, and other study issues • Coordinate study start-up activities and ensure timely ethics committee and regulatory submissions when appropriate • Ensure essential document quality meets Regulatory Compliance Review expectations • Review and follow up on ethics committee questions • Provide input into clinical activity forecast estimates • Manage clinical resources, assign and 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 • Equivalency through a combination of appropriate education, training and/or directly related experience may be considered • 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 a changing environment with complex/ambiguous situations • Familiarity with clinical monitoring practices, processes, and requirements • Good judgment and decision-making skills • Effective oral and written communication skills, including English language proficiency • Ability to evaluate workload against project budget and adjust resources accordingly • Sound financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Solid understanding of relevant regulations, including ICH/GCP and FDA guidelines • Good computer skills, including Outlook, Excel, Word, and computerized applications • Ability to frequently drive to site locations and travel domestically and internationally

🏖️ Benefícios

• Global team environment • Collaboration and development opportunities • Exposure to passion, innovation, and scientific excellence • Full-time employment • Fully remote work arrangement

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