Description
The Senior Associate, Central Monitor is responsible for ensuring the completeness, quality and integrity of subject data in the clinical trial database under Risk Based Monitoring (RBM) mode.
Key responsibilities include:
- Developing and implementing Risk-Based Monitoring systems for applicable studies
- Ensuring key risk indicators (KRIs) are properly defined and set up in the system
- Processing and reviewing study data in the system for signal and action management
- Collaborating with the global study team to meet study objectives
- Implementing quality oversight/control steps in central monitor activities
- Providing technical expertise to set up and test study-level Risk-based Monitoring systems
- Reviewing study-level system outputs to process for signal and action management
- Planning and executing communication plans to ensure customer satisfaction
- Resolving conflicts and influencing key stakeholders and customers
- Setting up and testing RBM systems at study level to ensure system quality
- Defining key risk indicators (KRIs) in study systems
- Setting up dictionaries for data quality assessment (DQA) in study systems
- Ensuring RBM systems align with protocols and adhere to regulatory requirements
- Working with study teams to define issue resolution for reviewing findings
- Developing and maintaining quality control-related documentation for RBM activities
- Performing central monitoring activities, including reviewing system outputs and proposing suggestions for signal and action management
- Working with Clinical Data Scientists to ensure signals and actions are properly mitigated
- Documenting lessons learned during the study and sharing with other central monitors/study teams