Senior Associate, Central Monitor, Data Surveillance, Clinical Data Sciences

Tasks

• Define Key Risk Indicators
• Develop risk based monitoring system
• Document and share lessons learned
• Ensure RBM activities comply with ICH GCP SOPs and regulations
• Ensure clinical trial data completeness quality integrity
• Follow up issue resolution
• Maintain quality control documentation for RBM activities
• Perform central monitoring activities
• Process review signals and actions
• Review study level outputs for signal and action management
• Set up data quality assessment dictionary
• Troubleshoot RBM system database issues

Perks/Benefits

• Healthcare benefits
• Hybrid work model
• Paid time off

Skills/Tech-stack

CRF design | Clinical Development | Clinical data | Clinical data management | Clinical trial | Clinical trial database | Data Management | Data cleaning | Database Design | Database Programming | Database setup | Edit Check | Edit Check Specifications | ICH GCP | Issue Resolution | Java | Microsoft Excel | Microsoft PowerPoint | Microsoft Project | Microsoft Word | Oracle | PLSQL | Project Management | Quality Control | Relational Database | Relational Database Design | Risk-Based Monitoring | Risk-based | SAS | Stakeholder management | Windows