Clinical Operations - Data Management - CTMS Systems Administrator
San Diego Metro Area, California
This position provides technical and operational leadership, support, and maintenance for one or more clinical systems, including Clinical Trial Management System (CTMS).
- The Clinical Operations Systems Administrator/Manager is directly responsible for the setup, maintenance and reporting from one or more clinical systems, including CTMS. Dependent on trial statuses, may provide leadership for other team members in the setup, maintenance and reporting on multiple trials/systems.
- Will serve as key liaison with parent organization to ensure consistent processes/procedures and data integrity are maintained.
- Responsible for the coordination and distribution of periodic safety reports through electronic systems to clinical trial investigators and ethics committees, including possibly serving as a backup team member to other global teams within the organization.
- Candidate will have a working understanding of clinical development through prior exposure to research protocols, development and study procedures, company Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) guidelines, and International Conference on Harmonization (ICH) Good Clinical Practices (GCPs).
- Provides feedback to department leadership regarding issues or potential improvements.
- Bachelor s degree with 5+ yrs of progressive experience with Clinical Operations or other relevant Research and Development function. Familiar with CRO oversight activities (e.g. monitoring, safety reporting, data collection).
Prior experience managing a CTMS or other clinical systems required.
Knowledge of medical terminology a plus.
Thorough understanding of principals of Good Clinical Practices is critical.