Project Manager – FSP Trial Lead

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🕒 Agosto 26

🌲 North Carolina – Remoto

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⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 25%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Lifelancer

51 - 200 funcionários

Fundada em 2020

💼 Consultoria

🏥 Saúde

📦 Logística

💰 Pre Seed Round em 2022-03

Consulting • Healthcare • Logistics

Lifelancer é uma plataforma de contratação de talentos impulsionada por IA que conecta empregadores a profissionais qualificados nos setores de Ciências da Vida, Farmacêutico e TI. Ela permite que indivíduos criem perfis exibindo suas habilidades, sejam correspondidos com empregos ou projetos internacionais bem remunerados, e facilita a contratação e folha de pagamento para empregadores em vários países. A plataforma visa simplificar o processo de contratação com uma captação eficiente usando IA e suporte de conformidade.

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 • Participate as part of the Study Management Team (SMT) • Implement and execute study plans to support successful clinical trial delivery • Work closely with global trial and functional leads • Clarify responsibilities and communication pathways for secondary project leads when required • Demonstrate financial stewardship at the trial level, including contract understanding, resource alignment to budget, out-of-scope activity management, Con Mod negotiations, and timeline execution • Establish, communicate, and manage customer expectations throughout the project • Drive project-level risk identification and issue resolution • Ensure compliance with organization policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements • Manage vendors when required • Delegate and prioritize the workload of project team members in a frequently changing environment

🎯 Requisitos

• B.A. or B. Sc. in a scientific discipline • 8+ years of comparable experience • 2+ years of project/trial management experience • 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) • Cross-functional drug development knowledge • 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 effectively prioritize work in a frequently changing environment • Effective oral and written communication and presentation skills • Proactive, solutions oriented, and adaptable to changing priorities and situations • Ability to negotiate, persuade, and influence others, including cross-cultural awareness • Prior neurology therapeutic experience required • Rare-disease experience preferred • Investigator site and/or monitoring experience preferred • Functional Service Provider (FSP) experience preferred • Ability to travel domestically and internationally • Advanced degree in a related field preferred

🏖️ Benefícios

• Ability to travel domestically and internationally

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