CRO – Project Manager

🕒 Ontem

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷‍♀️ Gerente de Projetos

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O que significa: quão provável esta vaga está aberta sem contratação ativa.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Como pontuamos: tempo em aberto, republicações, vagas abertas vs tamanho do time, rapidez para fechar vagas, e se o salário está divulgado.Observação: é uma estimativa de dados públicos, não um julgamento da empresa. Vagas reais podem ter pontuação alta, então use como uma dica, não como um fato.

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Evolution Research Group

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2014

💼 Consultoria

🏥 Saúde

🧬 Biotecnologia

Consulting • Healthcare • Biotechnology

A Evolution Research Group é uma organização de pesquisa clínica dedicada a avançar a ciência médica através de ensaios clínicos inovadores. Especializando-se em áreas terapêuticas como psiquiatria, neurologia, gestão da dor, dependência e várias condições crônicas, a ERG colabora com prestadores de saúde e organizações de defesa para garantir inclusão e recrutamento abrangente de pacientes. Com um banco de dados robusto de potenciais participantes e expertise em ensaios de fase inicial, a Evolution Research Group visa transformar a saúde apoiando o desenvolvimento de terapias que mudam vidas.

Descrição

• Assume primary accountability for assigned clinical research projects and ensure compliance with applicable regulations, guidelines, and corporate policies • Manage and execute project scope, budget, and timelines • Identify project success factors for analysis, reporting, and tracking • Manage resources and timelines for study start-up and implementation activities, including CRO/investigator agreements and contracts • Lead development of study-specific protocols, consent forms, and trial-related materials • Ensure development of study plans, case report form instructions, site selection materials, investigator updates, and other project documents • Participate in clinical data review for analysis • Ensure project tasks meet client expectations and comply with contracts, protocols, and SOPs • Serve as liaison between clients, internal teams, sponsors, and sites • Plan and manage materials supporting clinical project execution, including documents, forms, supplies, equipment, and investigational devices • Monitor contract and budget adherence • Coordinate with clinical, marketing, and operations management to define study goals and scope • Ensure operational and regulatory integrity and participate in FDA or other regulatory authority inspections as needed • Support management and oversight of clinical study vendors • Review site monitoring reports for SOP and contractual compliance • Provide therapeutic training and guidance to the clinical team • Participate in departmental or corporate initiatives and maintain current job knowledge • Perform other related duties as required

🎯 Requisitos

• Bachelor’s degree or equivalent education/degree in life science/healthcare is required • 5 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program • CRO experience is highly desirable • Experience qualifying and managing external vendors • Experience leading project operational teams through study start-up, study conduct, data management, and report writing of clinical studies • Experience writing, reviewing, and editing protocols and clinical study reports • Working knowledge of the FDA submission process • Extensive organizing and coordinating skills • Teaching and facilitation skills, including assessing training needs and objectives • Extensive experience overseeing and coordinating the work of others • Ability to handle multiple tasks simultaneously and manage multiple deadlines • Ability to exercise judgment and determine appropriate action for problems of varying complexity • Strong computer skills, including Microsoft Office

🏖️ Benefícios

• Attending off-site meetings and conferences, as needed • Educational opportunities, professional publications, personal networks, and professional organizations • Participation in departmental or corporate initiatives