Clinical Data Manager

🕒 Maio 8

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Sumitomo Pharma America, Inc.

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1001 - 5000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Sumitomo Pharma America, Inc. é dedicada a melhorar a saúde e o bem-estar de pessoas ao redor do mundo, impulsionando tratamentos inovadores, ciência e tecnologia. A empresa concentra-se em atender às necessidades dos pacientes em áreas críticas como psiquiatria e neurologia, oncologia, urologia, saúde da mulher, doenças raras e terapia celular e genética. Como uma subsidiária da Sumitomo Pharma Co. , Ltd. , a SMPA incorpora a promessa de combinar tecnologia e expertise em ciências da vida para melhorar os resultados dos pacientes. Com um pipeline diversificado de programas pré-clínicos e clínicos, a SMPA está comprometida em oferecer soluções centradas no paciente por meio de uma abordagem orientada pela tecnologia.

Descrição

• Execute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs • Support and contribute to the oversight of CROs and data management vendors, including review of deliverables, metrics, timelines, and issue escalation • Perform and/or oversee database build, edit check specification review, UAT planning and execution, database modifications, and database lock activities • Conduct ongoing data review, cleaning, query management, and quality control to ensure data accuracy, consistency, and completeness • Develop, review, and maintain Data Management deliverables, including: Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications • Monitor study status metrics and provide regular data management status updates to study teams and functional leadership • Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities • Identify operational risks, trends, and data quality issues using metrics, audits, and study insights, and partner with teams to implement corrective actions • Support inspection readiness activities, audits, and regulatory inquiries related to clinical data management

🎯 Requisitos

• Bachelor's degree in a scientific, health-related, or quantitative discipline required • Minimum 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry • At least 2 years in a Clinical Data Manager role • Oncology experience preferred • Strong working knowledge of clinical data management processes and regulatory requirements (ICH, GCP) • Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes • Strong organizational skills with ability to manage multiple priorities in a fast-paced environment • Ability to analyze data trends and operational risks to inform decision-making • Effective verbal and written communication skills • High attention to detail and problem-solving skills

🏖️ Benefícios

• Merit-based salary increases • Short incentive plan participation • Eligibility for 401(k) plan • Medical insurance • Dental insurance • Vision insurance • Life insurance • Disability insurance • Paid time off policy includes flexible paid time off • 11 paid holidays plus additional time off for shut down during last week of December • 80 hours of paid sick time upon hire and each year thereafter