The Senior Associate, Central Monitor is responsible for ensuring the completeness, quality, and integrity of the subject data in the clinical trial database under Risk-Based Monitoring (RBM) mode. The areas of activity include but are not limited to developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Senior Associate, Central Monitor ensures risk-based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Associate, Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Associate, Central Monitor works with the global study team to meet the study objectives.
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
- Able to resolve conflicts, influence, and communicate with key stakeholders and customers.
- Provide technical expertise to set up and test study level Risk-based Monitoring system
- Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
- Review study level system outputs to process for the signal and action management
- Implement quality oversight/control steps implemented in the central monitor activities.
Qualification & Experience:
- Bachelor’s degree or above or equivalent experience in a scientific or business-related discipline required.
- 3 – 5 years of working experience in the clinical development fields.
- Previous experience within a data management role, understanding key processes and principles associated with the role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
- Working knowledge of the clinical development process, understanding concepts of Phase I-IV and principles of study design
- Knowledge of clinical trial database and its applications