Overview: Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan, focused on addressing patient needs in various therapeutic areas including oncology, urology, women's health, rare diseases, cell & gene therapies, and CNS. We are currently seeking a skilled Clinical Data Management Specialist to join our team.

This role reports to the Executive Director of Clinical Data Management and is integral to our Oncology Data Management function. You will play a pivotal role in supporting clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data.

Key Responsibilities:
• Execute and manage clinical data management activities for assigned oncology trials, adhering to ICH/GCP and internal SOPs.
• Oversee CROs and data management vendors, assessing deliverables, timelines, and metrics.
• Conduct database build activities, including edit check specification review, UAT planning, and database modification.
• Perform ongoing data review, cleaning, and quality control to ensure data accuracy and completeness.
• Develop and maintain critical Data Management deliverables such as Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Monitor study status and provide updates to study teams and functional leadership.
• Collaborate cross-functionally to support data reconciliation and analysis readiness for submission activities.
• Identify operational risks, trends, and data quality issues, implementing corrective actions as necessary.
• Prepare for inspection readiness activities, audits, and regulatory inquiries related to clinical data management.
• Adhere to Data Management standards, processes, and best practices.
• Perform additional data management-related duties as required to support organizational objectives.

Knowledge, Skills, and Abilities:
• Strong understanding of clinical data management processes and regulatory requirements (ICH, GCP).
• Experience with EDC systems and data validation processes.
• Familiarity with oncology clinical trials and data flow is preferred.
• Ability to analyze data trends and operational risks to inform decision-making.
• Excellent organizational skills with the capability to manage multiple priorities.
• Effective verbal and written communication skills for cross-functional collaboration.
• High attention to detail and problem-solving skills.
• Able to work independently and thrive in a collaborative environment.

Education & Experience Requirements:
• Bachelor's degree in a scientific, health-related, or quantitative discipline is required.
• A minimum of 4 years of relevant clinical data management experience, including at least 2 years in a Clinical Data Manager role; oncology experience preferred.
• Equivalent combinations of education and experience may be considered.

Equal Employment Opportunity: Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender, disability, or any other characteristic protected by law.

Accessibility: Sumitomo Pharma America endeavors to make its application process accessible. For accommodation requests, please contact us specifically regarding accessibility needs.

Travel Requirements: This role is primarily remote with periodic on-site meetings. Domestic and international travel may be required.

Drug Screening: Applicants for designated roles may be required to submit to a pre-employment drug test.