Senior Project Manager – Dermatology/Rheumatology

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🕒 Agosto 21

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

👷‍♀️ Gerente de Projetos

👻 Score fantasma 12%

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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Innovaderm Research Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

💊 Farmacêutico

🏥 Saúde

💼 Consultoria

Pharmaceuticals • Healthcare • Consulting

Como uma CRO (Organização de Pesquisa por Contrato) especializada em dermatologia, fornecemos orientação científica, resultados precisos e satisfação do cliente. Nossa oferta de serviços única combina Serviços de Pesquisa Contratual especializados, conhecimento de locais de dermatologia na América do Norte e Europa e as capacidades ampliadas de um grande site de pesquisa clínica.

Descrição

• Serve as the primary contact for the Sponsor • Provide efficient and timely updates on trial progress • Lead client calls effectively • Oversee and actively participate in preparing study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports • Participate in planning and conducting the Investigator’s Meeting • Ensure each site has the materials needed to perform the study, including investigational products, study supplies, special equipment, and safety lab kits • Ensure assigned studies are audit ready at all times • Monitor the quality of study deliverables, including vendor and SubCRO deliverables, and address issues • Manage risks and control measures to assure project quality • Analyze discrepancies between planned and actual results • Review and approve responses to quality assurance audits • Control project budgets, especially internal hours allocated to activities • Identify out-of-scope activities for change orders • Manage trial timelines, budgets, resources, and vendors • Coordinate tasks and deliverables from all functional departments • Communicate with study team members, functional departments, and senior management • Manage and report recruitment status and identify initiatives needed to meet recruitment timelines • Lead the core project team, including Associate Project Managers, Project Coordinators, and Project Assistants • Ensure team members receive adequate project training • Collaborate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs teams and vendors

🎯 Requisitos

• At least 7 years of global clinical project management experience, including management of all project phases from start-up to closure, all functional services, and vendor management • At least 10 years of industry experience, including a minimum of 3 years in a CRO • Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) • Experience leading multicentered, multinational Phase III clinical trials, including project budget financial tracking and forecasting • B.Sc. in a related field of study to clinical research • Excellent knowledge of GCP and ICH standards and local country regulations • Excellent knowledge of Microsoft Office Suite • Fluency in English with excellent oral and written skills, required • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Strong ability to carry out different projects and work under pressure while meeting timelines • PMP or PRINCE2 certification is an asset • Experience in study start-up, regulatory submission, resource management, supervisory experience, CRA, data management, medical writing, or vendor management is an asset • Therapeutic experience managing dermatology, onco-dermatology, rheumatoid arthritis, or oncology trials is an asset • Bilingualism (English and local language) is an asset

🏖️ Benefícios

• Attractive advancement opportunities • Stimulating work environment • Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request • Equal opportunity and equitable treatment