Project Manager – FSP Trial Lead

🕒 Agosto 25

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

🦅 Patrocina Visto H1B

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👻 Score fantasma 10%

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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

• Serve as Project Lead and primary sponsor contact • Accountable for overall project delivery, including quality, time, and cost • Establish and communicate customer expectations to the project team • Ensure internal and external escalation pathways are followed • Lead cross-functional project teams to meet or exceed deliverables • Implement and execute study plans supporting successful clinical trial delivery • Work closely with Global Trial and functional leads • Define responsibilities and communication pathways for secondary project leads when required • Ensure financial stewardship at trial level, including contract understanding, resource alignment, out-of-scope activity management, Con Mod negotiations, and timeline execution • Drive project-level risk identification and issue resolution • Ensure compliance with organization policies, SOPs, ICH-GCP, regulatory, and project-specific requirements • Manage vendors where required • Delegate and prioritize the workload of project team members

🎯 Requisitos

• B.A. or B. Sc. in a scientific discipline • Previous experience comparable to 8+ years, including 2+ years of project/trial management • Related scientific and clinical expertise • Exceptional project-management, risk-assessment, contingency-planning, and communication skills • Extensive knowledge of clinical development related to one or more trial phases (I, II, III) • Knowledge of cross-functional drug development • Expertise in Good Clinical Practices (GCP), International Council for Harmonization (ICH) guidelines, and regulatory requirements for clinical development • Ability to establish and execute operational plans • Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, and organization systems • Ability to delegate and prioritize workload in a frequently changing environment • Effective oral, written communication, and presentation skills • Proactive, solutions-oriented, and adaptable to changing priorities and situations • Advanced therapeutic area knowledge and clinical development guidelines and directives • Sound interpersonal and customer service skills, including ability to lead, motivate, and coordinate cross-functional project teams • Ability to negotiate, persuade, and influence others, including cross-cultural awareness • Prior neurology therapeutic experience required • Ability to travel domestically and internationally

🏖️ Benefícios

• Fully remote work arrangement

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