Join Sumitomo Pharma Co., Ltd., a pioneering global pharmaceutical company, focused on meeting patient needs in oncology and various other health areas. We are committed to accelerating the discovery and development of novel therapies aimed at improving patient outcomes.

This role reports to the Executive Director of Clinical Data Management in our Oncology division and is integral to our clinical development efforts, ensuring that we maintain high-quality, compliant, and inspection-ready clinical trial data. The Oncology Clinical Data Manager will work closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors to execute and oversee clinical data management activities across oncology studies.

Key Responsibilities:
• Oversee and manage in-house clinical data management activities for assigned oncology trials according to ICH/GCP, regulatory requirements, and internal SOPs.
• Support the monitoring of CROs and data management vendors, including deliverables review, metrics tracking, timelines, and issue escalation.
• Perform and oversee processes including database build, edit check specification review, User Acceptance Testing (UAT) planning and execution, database modifications, and locking activities.
• Conduct ongoing data review, cleaning, and query management to ensure data accuracy and completeness.
• Develop, review, and maintain key Data Management deliverables such as Data Management Plans (DMPs) and Data Validation Specifications.
• Monitor study status metrics, providing regular updates on data management to study teams and functional leadership.
• Collaborate across functions to support data reconciliation and readiness for submission activities.
• Identify operational risks and data quality issues, partnering with teams to implement corrective actions.
• Ensure readiness for inspections and assist with audits and regulatory inquiries related to clinical data management.
• Adhere to best practices in Data Management standards and processes.

Qualifications:
• A Bachelor's degree in a scientific, health-related, or quantitative discipline.
• A minimum of 4 years of experience in clinical data management within the pharmaceutical or biotech industry, with at least 2 years in a Clinical Data Manager role. Experience in oncology is preferred.
• Strong knowledge of clinical data management processes and regulatory requirements.
• Proficiency with EDC systems and a clear understanding of oncology clinical trials.
• Able to analyze data trends and operational risks effectively.
• Excellent organizational, communication, and collaboration skills.
• High attention to detail and problem-solving abilities.
• Able to work both independently and as part of a diverse team.

Compensation and Benefits:

The base salary for this position ranges from $130,400.00 to $163,000.00, with a comprehensive total rewards package that includes merit-based salary increases, participation in a short incentive plan, and eligibility for the 401(k) plan. Our extensive time-off policy includes flexible paid time off, 11 paid holidays, an additional shut-down period, and generous sick leave.

At Sumitomo Pharma, we value diversity and inclusion. We encourage applicants from all backgrounds to apply, and we ensure a responsive and accessible application process for all candidates.

We look forward to your application and the possibility of you joining our mission to enhance healthcare outcomes globally.