This position reports to the Executive Director, Clinical Data Management, Oncology, and is a vital part of the Oncology Data Management team that supports Sumitomo Pharma America's clinical development programs. Our mission is to ensure high-quality, compliant, and inspection-ready clinical trial data. As a key player, you will be responsible for overseeing and executing all clinical data management activities throughout our oncology studies, collaborating closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.

Essential Functions:
• Oversee and execute all in-house clinical data management activities for allocated oncology trials according to ICH/GCP, regulatory mandates, and internal SOPs.
• Support oversight of CROs and data management vendors, including reviewing deliverables, tracking metrics, managing timelines, and escalating issues when necessary.
• Perform and/or supervise database construction, edit check specification review, user acceptance testing (UAT) planning and execution, database modifications, and database lock processes.
• Conduct ongoing data review, data cleaning, query management, and quality assurance to guarantee data accuracy, consistency, and completeness.
• Develop, review, and maintain comprehensive data management deliverables such as data management plans, CRF completion guidelines, data validation specifications, and data transfer specifications.
• Monitor study status metrics (e.g., enrollment, eCRF completion, query aging), providing regular updates to study teams and functional leadership about data management progress.
• Engage cross-functionally with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety teams to facilitate data reconciliation, analysis readiness, and submission activities.
• Identify operational risks, trends, and data quality issues using metrics, audits, and study insights, collaborating with teams to implement timely corrective actions.
• Support inspection readiness activities, audits, and any regulatory inquiries related to clinical data management.
• Ensure adherence to data management standards, processes, and best practices.
• Take on additional data management tasks as required to assist departmental and organizational goals.

Knowledge, Skills, and Abilities:
• In-depth understanding 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 procedures.
• Familiarity with oncology clinical trials, endpoints, and data flow preferred.
• Adept at analyzing data trends, metrics, and operational risks to facilitate informed decision-making.
• Strong organizational skills to manage multiple priorities in a fast-paced environment.
• Excellent verbal and written communication skills with a proven ability to collaborate effectively.
• High attention to detail, exceptional problem-solving skills, and sound judgment.
• Capacity to work independently while being an effective part of a data-driven team.

Education & Experience:
• Bachelor's degree in a scientific, health-related, or quantitative discipline is required.
• Minimum of 4 years of relevant clinical data management experience in the pharmaceutical or biotech industry, including at least 2 years in a Clinical Data Manager role. Oncology experience is preferred.
• Equivalent combinations of education and experience will be considered.

Compensation:

The base salary range for this role is $130,400.00 - $163,000.00. This salary is part of our comprehensive rewards package which also includes the opportunity for merit-based salary increases, participation in a short incentive plan, eligibility for our 401(k) plan, and comprehensive medical, dental, vision, life, and disability insurances. Our generous time-off policy includes flexible paid time off, 11 paid holidays, additional shutdown time during the last week of December, and 80 hours of paid sick time upon hire and yearly thereafter. Total compensation, including the offered base salary, will depend on unique candidate factors, including experience, skills, education, and other legal considerations.

Travel Requirements:

This is primarily a remote role with periodic on-site meetings. Candidates must be able to travel domestically and internationally as required.

Compliance and Confidentiality:

All information encountered in this position is considered confidential, following applicable laws. Candidates must achieve and maintain compliance with all regulatory, legal, and operational protocols, ensuring that all activities comply with the highest ethical standards.

Equal Employment Opportunity:

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment 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.