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Clinical Team Manager – Neuro

🕒 Novembro 4

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🗣️🇺🇸🇬🇧 Inglês obrigatório

De onde vem esta vaga

Publicada na página de carreiras da Thermo Fisher Scientific, não em um site de vagas

Vista pela primeira vez pelo Remote Rocketship Novembro 4

Ainda aberta no site da Thermo Fisher Scientific. Verificada 4 horas atrás.

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

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 or less complex projects when required • Develop clinical tools, monitoring plans, monitoring guidelines, and contribute to Data Quality Plans and Master Action Plans • Establish, organize, maintain, and archive relevant local and central 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 other departments; lead team meetings and maintain timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes and corporate policies • Prepare and monitor clinical activity timelines and metrics, provide project status updates, review projects with tracking tools, and implement recovery actions • Review monitoring visit reports, manage CRF collection and query resolution, and monitor or co-monitor clinical trials • Conduct Accompanied Field Visits and manage project financials in smaller regions when required • Communicate with study sites regarding protocols, patient participation, case report forms, and related issues • Coordinate study start-up activities and timely ethics committee and regulatory submissions • Ensure essential document quality and follow up on ethics committee questions • Provide input into clinical activity forecasts and manage clinical resources, assignments, delegations, and additional resource requirements

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities • Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities • Experience in end-to-end study management of studies • Early Phase and Start-up experience preferred • Familiarity with clinical monitoring practices, processes, and requirements • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • English language proficiency • Computer skills using Outlook, Excel, Word, and similar computerized applications • Leadership, mentoring, training, planning, organizational, interpersonal, problem-solving, judgment, decision-making, communication, financial management, budgeting, forecasting, fiscal management, and attention-to-detail skills • Ability to work effectively in a changing environment with complex or ambiguous situations • Ability to evaluate workload against project budget and adjust resources accordingly • Therapeutic-area experience in psychiatry, Parkinson's disease, sleep disorders, epilepsy, hearing loss, or listed rare diseases; CAR-T experience is a plus

🏖️ Benefícios

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

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Desenvolvido por Lior Neu-ner. Adoraria receber seu feedback — entre em contato por DM ou pelo e-mail support@remoterocketship.com
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