Sumitomo Pharma Co., Ltd.
pharmaceutical
ClinicalDataManager
Neural analysis suggests this role is
optimal for Mid candidates.
“Clinical Data Manager at Sumitomo Pharma Co., Ltd.. Skills: clinical data management, EDC systems, eCRF design, edit checks, data validation, database lock processes, Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, Data Transfer Specifications. 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 CR”
What You'll Achieve.
ensuring high-quality, compliant, and inspection-ready clinical trial data; data accuracy, consistency, and completeness; analysis readiness; submission activities
Industry & Context.
problem-solving skills
Primarily remote role with periodic on-site meetings in office, Must be able to travel domestically and internationally as needed, Requires ability to use a personal computer for extended periods of time
What They're Looking For.
Must Have
Bachelor's degree in a scientific, health-related, or quantitative discipline, 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, working knowledge of clinical data management processes, working knowledge of clinical trial conduct, working knowledge of regulatory requirements (ICH, GCP), Experience with EDC systems, Experience with eCRF design, Experience with edit checks, Experience with data validation, Experience with database lock processes
Nice to Have
Understanding of oncology clinical trials, endpoints, and data flow, Oncology experience
What You'll Do.
Execute and manage all in house clinical data management activities for assigned oncology trials in accordance with ICH/GCP
regulatory requirements
Support and contribute to the oversight of CROs and data management vendors
including review of deliverables
Perform and/or oversee database build
edit check specification review
UAT planning and execution
database modifications
and database lock activities
Conduct ongoing data review
and quality control to ensure data accuracy
and maintain Data Management deliverables
Monitor study status metrics (e. g.
query aging) and provide regular data management status updates to study teams and functional leadership
Collaborate cross functionally with Clinical Operations
and Safety to support data reconciliation
and submission activities
Identify operational risks
and data quality issues using metrics
and partner with teams to implement corrective actions
Support inspection readiness activities
and regulatory inquiries related to clinical data management
Ensure adherence to Data Management standards
Perform other data management–related duties as required to support departmental and organizational objectives
How You'll Work.
Team & Collaboration
works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors; Collaborate cross functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to support data reconciliation, analysis readiness, and submission activities; contributing effectively as part of a matrixed team environment
Communication Scope
Effective verbal and written communication skills; Excellent written and oral communication skills
Process & Methodology
ability to manage multiple priorities in a fast-paced environment
Full Job Description
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website [_https://www.us.sumitomo-pharma.com_](https://www.us.sumitomo-pharma.com) or follow us on LinkedIn. # This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America’s clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors. **Essential Functions Required for the Job** * 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 * Dat
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