Clinical Data Manager

Sumitomo Pharma America, Inc.

Clinical Data Manager overseeing oncology clinical trials for Sumitomo Pharma America. Ensuring compliance with regulations and managing data for high-quality clinical trial outcomes.

Posted 5/8/2026full-timeRemote • 🇺🇸 United StatesMid-LevelSenior💰 $130,400 - $163,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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, and Data Transfer Specifications
Monitor study status metrics 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

Requirements

What you’ll need

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
At least 2 years in a Clinical Data Manager role
Oncology experience preferred
Strong working knowledge of clinical data management processes and regulatory requirements (ICH, GCP)
Experience with EDC systems, eCRF design, edit checks, data validation, and database lock processes
Strong organizational skills with ability to manage multiple priorities in a fast-paced environment
Ability to analyze data trends and operational risks to inform decision-making
Effective verbal and written communication skills
High attention to detail and problem-solving skills

Benefits

Comp & perks

Merit-based salary increases
Short incentive plan participation
Eligibility for 401(k) plan
Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
Paid time off policy includes flexible paid time off
11 paid holidays plus additional time off for shut down during last week of December
80 hours of paid sick time upon hire and each year thereafter

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementdatabase buildedit check specificationUAT planningdata cleaningquery managementdata validationdata transfer specificationsdata accuracydata quality control

Soft Skills

organizational skillsproblem-solving skillscommunication skillsattention to detailability to manage multiple prioritiesanalytical skills