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.
- Provide technical expertise to set up and test study level Risk-based Monitoring system
- Able to resolve conflicts, influence and communicate with key stakeholders and customers.
- 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.
- Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
Qualification & Experience:
- 3 – 5 years working experience in the clinical development fields.
- Bachelor’s degree or above of equivalent experience in a scientific or business related discipline required.
- Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design