Clinical Data ManagerSumitomo Pharma America, Inc. • New York, New York, United States
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Clinical Data Manager
Sumitomo Pharma America, Inc.
- New York, New York, United States
- New York, New York, United States
About
Responsibilities
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 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.
Additional Responsibilities
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.
Qualifications
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.
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 (required).
Oncology experience preferred.
Equivalent combination of education and experience may be considered.
Benefits
Base salary range: $130,400 - $163,000.
Merit-based salary increases, short incentive plan participation, and eligibility for a 401(k) plan.
Medical, dental, vision, life, and disability insurances.
Flexible paid time off, 11 paid holidays, additional time off during the last week of December, and 80 hours of paid sick time upon hire and each year thereafter.
Travel and Work Environment 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.
Physical and Mental Requirements Fast-paced environment handling multiple demands. Must 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.
Equal Employment Opportunity Sumitomo Pharma America (SMPA) is an equal employment opportunity 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.
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Languages
- English
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