Project Manager

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🕒 Agosto 21

🇦🇷 Argentina – Remoto

⏰ Tempo Integral

🟡 Pleno

🟠 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

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects • Ensure compliance with study budgets, project scope, timelines, SOPs, good clinical practices, regulatory and study-specific requirements • Serve as primary contact for sponsors, vendors and internal teams throughout studies • Coordinate tasks and deadlines across departments • Oversee project coordinators, SSU team members, RDA and RAC resources, prioritizing site activation activities • Coordinate vendor supplies and services with site activation timelines • Escalate site activation risks to Project Manager II • Assist with managing sponsor and stakeholder needs and expectations • Assist with team training and plan project activities and resources • Manage quality of assigned work and deliverables • Provide project status updates to internal and external stakeholders • Reconcile study trackers and analyze planned-versus-actual discrepancies • Participate in corrective actions, change control and risk management • Review and assist with drafting project operational plans, processes and manuals • Ensure study documents and deliverables meet country requirements • Oversee site feasibility, selection and qualification visit planning • Monitor patient recruitment and site recruitment strategy plans • Participate in Investigator’s Meetings • Oversee central ethics and regulatory submissions with Regulatory Affairs • Collect and maintain essential site documents throughout studies • Assist with TMF quality reviews and audits for inspection readiness • Support clinical monitoring activities, including CRA training, visit report review, site letters and escalated site issues • Track site visits, project training, monitoring reports, follow-up letters and site issue escalations • Maintain project-specific training matrix and verify team training completion • Ensure sites have required materials, investigational products, supplies, equipment and safety lab kits • Work with Data Management to ensure CRF compliance, query resolution and data review through database lock • Provide technical, therapeutic and project management expertise in training and departmental process improvement

🎯 Requisitos

• B.Sc. in a related field of study to clinical research • At least 3 years of experience in a similar role, including activities related to management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry • At least 2 years experience coordinating activities related clinical trial management • Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations • Excellent knowledge of Microsoft Office suite • Excellent oral and written skills in English • French is an asset • Excellent communication skills • Ability to work in a team environment and establish good relationships with colleagues and sponsors • Good problem-solving abilities • Good organizational skills • Strong ability to carry out different projects and work under pressure while meeting timelines • Experience managing small to medium projects using a disciplined approach to project management • Demonstrated ability to establish and deliver resource-based project plans • Excellent people management skills; experience working with and managing teams in a matrix environment • Must be legally authorized to work in Argentina

🏖️ Benefícios

• Flexible work schedule / work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Recruitment and selection accommodations for applicants with disabilities, upon request