Project Lead – Project Manager

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🕒 Maio 29

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

🦅 Patrocina Visto H1B

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🧬 Biotecnologia

💊 Farmacêutico

🔬 Ciência

Biotechnology • Pharmaceuticals • Science

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 the Project Lead and primary sponsor contact. • Accountable for overall delivery of the project (quality, time, cost). • Establish and communicate customer expectations to the project team. • Lead cross-functional project team to meet or exceed deliverables. • Ensure compliance with organization policies, SOPs, ICH-GCP. • Responsible for vendor management and financial stewardship at a trial level. • Drive Risk Identification and Issue Resolution at project level. • Manage out-of-scope activity and negotiate contracts.

🎯 Requisitos

• B.A. or B. Sc. in a scientific discipline. • 6 + years in clinical operations management, managing clinical trials per quality, timeline, and budget expectations, preferably with a Sponsor company and a CRO. • Related scientific and clinical expertise and 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), as well as 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, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems. • Ability to delegate and effectively prioritize own and workload of project team members in a frequently changing environment. • Effective oral and written communication and presentation skills. • Proactive, solutions oriented and adaptable to changing priorities and situations.

🏖️ Benefícios

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development opportunities