Remote Clinical Data Manager

About the job Remote Clinical Data Manager


37491749 - Remote Clinical Data Manager - Oncology, 6 Months Contract


Sigma, Inc. is currently looking for a Clinical Data Manager - Oncology to work remotely with our client located in Marlborough, MA.

Job Summary

The Clinical Data Manager will support Oncology clinical development programs and be responsible for the execution and oversight of clinical data management activities across assigned studies. This position will ensure clinical trial data is accurate, compliant, high quality, and inspection ready.

The Clinical Data Manager will work closely with Clinical Operations, Biostatistics, Medical Monitoring, Safety, Clinical Systems, and external CRO/data management vendors.

Responsibilities

• Manage clinical data management activities for assigned oncology clinical trials in accordance with ICH/GCP, regulatory requirements, and internal SOPs.
• Support oversight of CROs and data management vendors, including deliverables, timelines, metrics, and issue escalation.
• Perform and/or oversee database builds, edit check specification reviews, UAT planning and execution, database modifications, and database lock activities.
• Conduct ongoing data review, data cleaning, query management, and quality control.
• Develop, review, and maintain Data Management Plans (DMPs), CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications.
• Monitor study metrics, including enrollment, eCRF completion, and query aging, and provide status updates to study teams.
• Collaborate with Clinical Operations, Medical Writing, Medical Monitoring, Biostatistics, and Safety on data reconciliation, analysis readiness, and submission activities.
• Identify operational risks, trends, and data quality issues and support corrective actions.
• Support audits, inspection readiness, and regulatory inquiries related to clinical data management.
• Ensure adherence to Data Management standards, processes, and best practices.

Qualifications

• Bachelor's degree in a scientific, health-related, or quantitative discipline required.
• Minimum 4 years of relevant Clinical Data Management experience within the pharmaceutical or biotech industry.
• At least 2 years of experience in a Clinical Data Manager role .
• Experience with EDC systems, eCRF design, edit checks, data validation, UAT, and database lock processes.
• Strong knowledge of clinical trials, Clinical Data Management processes, ICH/GCP, and regulatory requirements.
• Oncology clinical trial experience preferred.
• Experience working with CROs and/or external data management vendors preferred.
• Strong organizational, analytical, problem-solving, and communication skills.
• Ability to manage multiple priorities and work independently within a cross-functional, matrixed environment.