Sumitomo Pharma Co., Ltd. is a leading global pharmaceutical company committed to addressing patient needs in fields such as oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. With a diverse pipeline of innovative investigational assets and several marketed products, we strive to accelerate research and development to deliver novel therapies to patients expediently.

This position reports to the Executive Director of Clinical Data Management in our Oncology Data Management function. It plays a crucial role in supporting the clinical development programs at Sumitomo Pharma America by ensuring that clinical trial data is of the highest quality, compliant, and inspection-ready. You will collaborate closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.

Key Responsibilities:
• Manage and execute clinical data management activities for assigned oncology trials in compliance with ICH/GCP, regulatory requirements, and internal SOPs.
• Oversee and support the activities of CROs and data management vendors, including deliverables review, metrics monitoring, timelines, and issue escalation.
• Perform and/or supervise database build, edit check specifications, UAT planning and execution, database modifications, and database lock activities.
• Conduct data cleaning, query management, and quality control to ensure the accuracy and integrity of data.
• Develop and maintain Data Management deliverables including Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Monitor and report on study status metrics (enrollment, eCRF completion, query aging) to study teams and leadership.
• Collaborate with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to ensure data reconciliation and analytical readiness for submissions.
• Identify operational risks and data quality issues through metrics and audits, implementing corrective actions as necessary.
• Support inspection readiness activities, audits, and regulatory inquiries related to data management.
• Ensure adherence to best practices and Data Management standards.

Qualifications:
• Bachelor's degree in a scientific, health-related, or quantitative discipline required.
• A minimum of 4 years of clinical data management experience in the pharmaceutical or biotech industry, including at least 2 years in a Clinical Data Manager role. Oncology experience preferred.
• Strong understanding of clinical data management processes, 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 and operational risks for informed decision-making.
• Excellent organizational skills and capacity to manage multiple priorities in a fast-paced environment.
• Effective verbal and written communication skills with the ability to collaborate cross-functionally.
• A keen attention to detail, problem-solving abilities, and sound judgment.
• Proven ability to work independently while effectively contributing to a matrixed team environment.

The base salary range for this role is $130,400.00 - $163,000.00. This is part of a comprehensive total rewards package, which includes opportunities for merit-based salary increases, short incentive plan participation, and eligibility for our 401(k) plan. We offer medical, dental, vision, life and disability insurances, flexible paid time off, 11 paid holidays, and a shutdown period during the last week of December, as well as 80 hours of paid sick time upon hire and annually thereafter.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity employer. We encourage qualified applicants to apply without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity, sexual orientation, disability, veteran status, or any other characteristic protected by law.

Our commitment to compliance with all applicable regulatory, legal, and operational procedures is paramount. We strive to meet the highest ethical standards in all of our practices.

This role requires flexibility, strong initiative, and excellent communication skills. Must be able to work independently in a remote capacity and occasionally participate in on-site meetings. Travel may be required both domestically and internationally.