Project Manager II

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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

• Take overall responsibility for the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical trials • Oversee and coordinate study resources to ensure compliance with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements • Act as the main communication line to relevant stakeholders • Provide input to feasibility, study design and budget development, and ensure progress reporting on resources, budget and timeline • Serve as primary contact for the Sponsor and provide timely trial-progress updates • Lead client calls • Oversee and actively participate in preparation of study plans, protocols, informed consent forms, eCRFs, TLFs and clinical study reports • Participate in planning and conducting Investigator Meetings • Ensure sites have required investigational products, study supplies, equipment and safety lab kits • Lead study start-up, including kick-off, TMF setup, site selection and activation, vendor setup, contracting and budgeting • Collaborate with Regulatory Affairs on submissions and essential documents • Partner with Data Management on CRF alignment, data review, query resolution and database lock timelines • Keep studies audit ready and monitor study, vendor and SubCRO deliverable quality • Manage risks and quality-control measures; analyze planned versus actual results • Review and approve responses to quality assurance audits • Control project budgets and internal hours; identify out-of-scope activities for change orders • Manage clinical-trial timelines, budgets, resources and vendors, coordinating cross-functional tasks and deliverables • Communicate with study teams, functional departments and senior management • Manage and report recruitment status and initiatives • Lead the core project team and ensure project training • Coordinate with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics and Scientific Affairs • Maintain project-specific training matrices and up-to-date training records

🎯 Requisitos

• B.Sc. in a related field of study to clinical research • At least 5 years industry experience • Minimum of 3 years in Phase I-III clinical trial project management • Experience managing dermatology and/or rheumatology trials • Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD • 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 • Applicants must be legally able to work in Argentina

🏖️ Benefícios

• Flexible work schedule / work schedule • Home-based position • Ongoing learning and development • Attractive advancement opportunities • Equitable treatment and equal opportunity • Accommodations throughout the recruitment and selection process to applicants with disabilities, upon request