Global Study Lead – FSP Team

🕒 Junho 5

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟠 Sênior

🦅 Patrocina Visto H1B

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👻 Score fantasma 45%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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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

• Lead the operational strategy, planning and delivery of the study/studies end to end from CSI (Commit to Study Initiation) until study archiving. • Provide oversight and support to the GSM and SM on end-to-end clinical study delivery. • Ensure compliance with ICH/GCP guidelines. • Accountable for translating asset requirements to the study and appropriate communication with the Clinical Operations Asset Lead. • Balance risk/benefit to make decisions based on clear understanding of impact on the study and project. • Ensure appropriate stakeholder communication, including study status, expectations, risks and issues. • Effectively build and lead empowered matrix teams. • Implement innovative approaches to study delivery through advances in technology and sciences. • Oversee quality efforts to ensure protocol compliance and continual inspection readiness for assigned studies.

🎯 Requisitos

• Bachelor’s degree: life sciences or related discipline • Highly experienced strategic leader capable of performing study accountable role in an autonomous way across multiple studies or a single large / complex study. • Extensive clinical development experience and proven experience in driving operational study delivery to time, cost, and quality within the pharmaceutical industry or CRO environment. • Proven operational experience of leading high performing global study teams in clinical trials. • In-depth knowledge of study management and knowledge of essential global regulatory guidelines and ICH/GCP. • Excellent project management skills and budget management skills.

🏖️ Benefícios

• Health insurance • Professional development opportunities • Paid time off

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