Senior Central Monitor

Vaga não está no LinkedIn

🕒 Setembro 18

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👻 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

• Perform remote site monitoring and management activities for assigned projects • Support clinical monitoring teams in implementing study strategies, initiatives, processes, and standards • Support collection of data and report generation for recruitment plans, enrollment, drug supply status, site payment status, and other clinical trial tracking • Support data risk assessments as assigned • Support monitoring teams throughout the study, including communication with clinical site institutions as appropriate • Support document collection, visit preparation, study data review, and central monitoring activities as assigned • Follow Standard Operating Procedures, regulatory requirements, ICH and GCP guidelines, and study-specific plans • Perform other duties as assigned

🎯 Requisitos

• Effective communication and interpersonal skills with ability to partner with cross-functional internal and external stakeholders • Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures • Ability to contribute to development of tools and processes that increase measured project efficiencies • Proficiency with clinical trial execution systems, including Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems • Good understanding of general quality assurance concepts and practices • Highly organized with strong attention to detail • Bachelor’s degree preferred • Persons without a formal degree may be considered if they have comparable depth and breadth of training and experience and meet job-specific criteria • Minimum 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or a relevant regulated environment • Working knowledge of CluePoints RBQM System desired • Long-haul COVID/Pulmonary experience desired • Compliance with FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans

🏖️ Benefícios

• Remote working support • Hybrid working encouraged for new hires within a reasonably short commute of an office, as agreed with the manager • Equal Opportunity Employer workplace • Diversity, equity, and inclusion commitment • Safe and empowering workplace environment

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