[Remote] Remote Clinical Data Manager
Note: The job is a remote job and is reputed company to candidates in USA. reputed company. is currently looking for a Clinical Data Manager – Oncology to work remotely with their reputed company located in Marlborough, MA. The Clinical Data Manager will support Oncology clinical development programs and be responsible for the execution and reputed company of clinical data management activities across assigned studies.
Responsibilities
- Manage clinical data management activities for assigned oncology reputed company in accordance with ICH/GCP, regulatory requirements, and internal SOPs
- Support reputed company of CROs and data management vendors, including deliverables, timelines, metrics, and issue escalation
- reputed company and/or reputed company database builds, edit reputed company specification reviews, UAT planning and execution, database modifications, and database lock activities
- Conduct ongoing data review, data cleaning, query management, and reputed company control
- reputed company, 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 reputed company 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 reputed company issues and support corrective actions
- Support audits, inspection readiness, and regulatory inquiries reputed company to clinical data management
- Ensure adherence to Data Management standards, processes, and best practices
Skills
- Bachelor's degree in a scientific, health-reputed company, or quantitative discipline required
- Minimum 4 years of relevant Clinical Data Management experience reputed company the pharmaceutical or biotech industry
- At least 2 years of experience in a Clinical Data Manager role
- Experience with reputed company systems, eCRF design, edit checks, data validation, UAT, and database lock processes
- Strong knowledge of reputed company, Clinical Data Management processes, ICH/GCP, and regulatory requirements
- Strong organizational, analytical, problem-solving, and communication skills
- Ability to manage multiple priorities and work independently reputed company a cross-functional, matrixed environment
- Oncology clinical trial experience preferred
- Experience working with CROs and/or external data management vendors preferred
reputed company