Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Execute and oversee all internal clinical data management tasks for designated oncology trials, ensuring compliance with ICH/GCP, regulatory standards, and internal SOPs.

• Assist in the oversight of CROs and data management vendors, which includes reviewing deliverables, metrics, timelines, and escalating issues as necessary.

• Carry out and/or supervise database construction, edit check specification reviews, UAT planning and execution, database modifications, and locking activities.

• Perform continuous data reviews, cleaning, query management, and quality control to guarantee data accuracy, consistency, and completeness.

• Create, review, and maintain Data Management deliverables such as Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.

• Track study status metrics and provide consistent data management status updates to study teams and functional leadership.

• Collaborate across functions with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety to facilitate data reconciliation, analysis readiness, and submission tasks.

• Detect operational risks, trends, and data quality concerns through metrics, audits, and study insights, partnering with teams to implement corrective measures.

• Assist with inspection readiness activities, audits, and regulatory inquiries related to clinical data management.

⛳️ Requirements

• A Bachelor's degree in a scientific, health-related, or quantitative field is required.

• At least 4 years of relevant experience in clinical data management within the pharmaceutical or biotech sector.

• Minimum of 2 years in a Clinical Data Manager position.

• Experience in oncology is preferred.

• Comprehensive knowledge of clinical data management processes and regulatory requirements (ICH, GCP).

• Familiarity with EDC systems, eCRF design, edit checks, data validation, and database lock procedures.

• Excellent organizational skills with the ability to handle multiple priorities in a dynamic environment.

• Capacity to analyze data trends and operational risks for informed decision-making.

• Strong verbal and written communication abilities.

• Exceptional attention to detail and problem-solving capabilities.

🏝️ Benefits

• Merit-based salary increases.

• Participation in a short incentive plan.

• Eligibility for a 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 during the last week of December shutdown.

• 80 hours of paid sick time upon hire and every year thereafter.