Senior Clinical Trials IT Business Analyst

🕒 Maio 18

🗽 New York – Remoto

🗽 New York – Remote

💵 $100.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

🧐 Analista de Negócios

👻 Score fantasma 45%

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.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

ACM Global Laboratories

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

ACM Global Laboratories é um fornecedor líder de serviços de teste para ensaios clínicos, apoiando testes clínicos globalmente em mais de 65 países. A empresa oferece uma gama de serviços bioanalíticos, incluindo análise de pequenas e grandes moléculas, análise de biomarcadores e várias soluções de testes laboratoriais, como testes de segurança de rotina, citometria de fluxo e rastreamento avançado de amostras. ACM Global Laboratories é reconhecida por sua experiência em serviços de bioanálise e toxicologia, garantindo alta sensibilidade e precisão nas medições de fármacos e metabólitos em diversas amostras biológicas. A empresa é dedicada a fornecer insights clínicos acionáveis e serviços de toxicologia confiáveis para provedores de saúde, colaborando com ensaios clínicos para otimizar projetos de desenvolvimento através de serviços laboratoriais de ponta, gerenciamento de amostras e logística global.

Descrição

• Serve as a strategic liaison between Clinical Development and Information Technology. • Lead the analysis, design, implementation, and optimization of clinical trial technology solutions supporting global clinical research operations. • Obtain, analyze, and document business, functional, and technical requirements. • Translate clinical and non-clinical operational needs into system configurations and technical solutions. • Develop BRDs, functional specifications, user stories, acceptance criteria, business process flow diagrams, and data flow diagrams. • Conduct system impact assessments and gap analyses. • Support system integration design across enterprise platforms. • Lead or support implementation, upgrades, enhancements, optimization, and maintenance of LIMS, LIS, Site Companion, Confident Rx, Enhanced One Portal, Electronic Lab Notebooks, and Validation Lifecycle Management systems. • Configure and support system enhancements; coordinate vendors and technical solution delivery. • Support change request management and release management processes. • Support CSV/CSA activities, validation plans, risk assessments, IQ/OQ/PQ testing, and validation documentation. • Ensure compliance with 21 CFR Part 11, ICH-GCP, FDA regulations, GxP standards, MHRA, GDRP, and MOH requirements. • Participate in audit and inspection readiness efforts. • Collaborate on APIs, HL7, middleware, data integrity, data migration, master data governance, reconciliation, and reporting requirements. • Lead UAT, develop test scripts, coordinate execution, manage defect tracking and resolution, support regression testing and release validation. • Facilitate deployment and post-go-live support. • Act as primary IT liaison for Clinical business stakeholders. • Facilitate workshops and requirements sessions. • Support Agile, PMBOK, or hybrid project methodologies. • Contribute to project plans, risk logs, and status reporting. • Provide training and change management support.

🎯 Requisitos

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, or related field. • 3 years of experience in clinical research and/or clinical IT systems. • 3 years in Business Analysis within regulated (GxP) environments. • Sedentary work capability: exerting up to 10 pounds of force occasionally. • Preferred: Master’s degree (MBA, MS, MPH, MHA). • Preferred: CBAP, PMI-PBA, PMP, or Agile certifications. • Preferred: Experience in global clinical trial environments. • Preferred: Knowledge of CDISC, SDTM, and clinical data standards. • Preferred: Experience with reporting tools such as Power BI, Tableau, or Qlik. • Preferred: Familiarity with cloud-based clinical systems such as Veeva, Medidata, Oracle Clinical, or BioClinical. • Preferred: Strong understanding of the lab clinical trial lifecycle. • Preferred: Hands-on experience with LIMS/LIS clinical platforms. • Preferred: Experience with system validation and regulatory compliance. • Preferred: Familiarity with system integrations and data workflows. • Preferred: Technical fluency in enterprise applications. • Preferred: Regulatory compliance expertise. • Preferred: Cross-functional leadership. • Preferred: Vendor management skills. • Preferred: Excellent communication and documentation skills.