Job Description
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
This position reports to the Executive Director, Clinical Data Management, Oncology and is part of the Oncology Data Management function, which supports Sumitomo Pharma America's clinical development programs by ensuring high-quality, compliant, and inspection-ready clinical trial data. The role is responsible for the end-to-end execution and oversight of clinical data management activities across assigned oncology studies and works closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external vendors.
Essential Functions Required for the Job - 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.
Knowledge, Skills, and Abilities - 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.
- Understanding of oncology clinical trials, endpoints, and data flow preferred.
- 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.
Education & Experience Requirements - 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.
- Oncology experience preferred.
- Equivalent combination of education and experience may be considered.
The base salary range for this role is
$130,400.00 - $163,000.00
Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements: Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Travel Requirements: Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.
Drug Screening Requirements Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
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, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at reasonableaccomodations@us.sumitomo-pharma.com. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Job Tags
Work at office, Remote work, Flexible hours