Senior Associate, Senior Central Monitor, Data Surveillance, Clinical Data Sciences
IND - Chennai Office, India
INR 1588K-2541K (estimate) Senior-level Full Time
Tasks
- Coordinate central monitor activities
- Define issue resolution for signal and action
- Develop and maintain quality control documentation for RBM activities
- Document and share lessons learned
- Ensure RBM system aligns with ICH GCP SOPs and regulations
- Ensure subject data completeness quality and integrity
- Follow up issue resolution
- Implement risk based monitoring systems
- Mitigate signals and actions with clinical data scientist
- Perform central monitoring activities for system outputs
- Process review findings for signal and action management
- Review protocols for set up review and reporting requirements
- Set up and test RBM system at study level
- Set up key risk indicators
Perks/Benefits
- N/A
Skills/Tech-stack
Action Management | CRF design | Clinical trials | Data Management | Data cleaning | Database Design | Database Programming | Database setup | Edit Check | Edit Check Specifications | ICH GCP | Java | Key Risk Indicators | Microsoft Excel | Microsoft PowerPoint | Microsoft Project | Microsoft Word | Oracle | PL/SQL | Project Management | Quality Control | Relational Database | Relational Database Design | Risk indicators | Risk-Based Monitoring | Risk-based | S&OP | SAS | Signal and Action Management | Windows
Education
Bachelor of Engineering | Bachelor of Science | Master of Science
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