[Remote] Clinical Data Manager

Note: The job is a remote job and is open to candidates in USA. Sumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health domains. The Clinical Data Manager will oversee clinical data management activities for oncology studies, ensuring high-quality and compliant clinical trial data in collaboration with cross-functional teams.

Responsibilities

• 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
• Data Transfer Specifications
• Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) 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
• Ensure adherence to Data Management standards, processes, and best practices
• Perform other data management–related duties as required to support departmental and organizational objectives

Skills

• 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, Data Transfer Specifications
• Monitor study status metrics (e.g., enrollment, eCRF completion, query aging) 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
• Ensure adherence to Data Management standards, processes, and best practices
• Perform other data management–related duties as required to support departmental and organizational objectives
• Strong working knowledge of clinical data management processes, clinical trial conduct, and regulatory requirements (ICH, GCP)
• Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes
• Ability to analyze data trends, metrics, and operational risks to inform decision‑making
• Strong organizational skills with the ability to manage multiple priorities in a fast‑paced environment
• Effective verbal and written communication skills and ability to collaborate cross‑functionally
• High attention to detail, problem‑solving skills, and sound judgment
• Ability to work independently while contributing effectively as part of a matrixed team environment
• 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, with at least 2 years in a Clinical Data Manager role
• Understanding of oncology clinical trials, endpoints, and data flow preferred
• Oncology experience preferred

Benefits

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for our 401(k) plan
• Medical, dental, vision, life and disability insurances
• Leaves provided in line with your work state
• Flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

Company Overview

Company H1B Sponsorship