Clinical Team Manager – Senior

🕒 Agosto 2

🤠 Texas – Remoto

🤠 Texas – Remote

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

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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 all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. • Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. • Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. • Collaborate with the clinical team and other departments as needed to meet deliverables of the project. • Responsible for the implementation and training of standardized clinical monitoring processes within the study. • Ensure achievement of the final clinical deliverable within the contractual time period specified. • Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. • May coordinate all start-up activities, and ensure that essential document quality meets the expectation of Regulatory Compliance Review.

🎯 Requisitos

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies. • Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams. • Strong planning and organizational skills to enable effective prioritization of workload and workload of team members. • Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization. • Solid understanding of change management principles. • Comprehensive understanding of the practices, processes, and requirements of clinical monitoring. • Strong judgment, decision making, escalation, and risk management skills. • Effective oral and written communication skills, including English language proficiency. • Capable of evaluating own and team members workload against project budget and adjust resources accordingly. • Strong financial acumen and knowledge of budgeting, forecasting and fiscal management. • Strong attention to detail. • In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Capable of independently managing clinical only studies.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options