Clinical Team Manager – Neuro

🕒 Julho 14

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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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 and contribute to the Data Quality Plan, Master Action Plan, and Trial Master File • Participate in designing CRFs, CRF guidelines, informed consent templates, and other protocol-specific documents • Collaborate with project managers and clinical teams to prepare and present client meetings • Lead team meetings and maintain project timelines, resources, interactions, and quality • Implement and train teams on standardized clinical monitoring processes • Ensure timely archiving of study documents and materials • Monitor clinical activity timelines and metrics, provide status updates, implement recovery actions, review monitoring visit reports, and manage CRF collection and query resolution • Continuously monitor or co-monitor clinical trials and ensure contractual obligations are met • Communicate with study sites regarding protocol, patient participation, CRF completion, and other study issues • Coordinate study start-up activities and 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, delegation, 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 healthcare, nursing, medicine, or related-discipline experience may be considered with clinical trial experience and significant clinical expertise • Experience in end-to-end study management • Early Phase and Start-up experience preferred • Therapeutic experience in Neurology and listed related therapeutic areas preferred; CAR-T experience a plus • Leadership, mentoring, training, team motivation, and integration skills • Planning, organization, prioritization, interpersonal, and problem-solving skills • 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 • Financial acumen and knowledge of budgeting, forecasting, and fiscal management • Strong attention to detail • Understanding of relevant regulations, including ICH/GCP and FDA guidelines • Computer skills using Outlook, Excel, Word, and computerized applications • Ability to work in a changing environment with complex or ambiguous situations • Frequent domestic and international travel to site locations

🏖️ Benefícios

• Collaboration and development opportunities • Reasonable accommodation for individuals with disabilities • Equal opportunity employment