Senior Central Monitor, Data Surveillance, Clinical Data Sciences
IND - Chennai Office, India
INR 2037K-2573K (estimate) Senior-level Full Time
Tasks
- Conduct central monitoring activities
- Define key risk indicators consistency
- Develop quality control documentation for RBM activities
- Develop risk based monitoring system
- Document lessons learned for cross study learning
- Ensure clinical trial data completeness
- Ensure clinical trial data integrity
- Ensure clinical trial data quality
- Ensure compliance with ICH/GCP
- Ensure compliance with SOPs
- Follow up issue resolution
- Implement quality oversight and control steps
- Manage issue resolution workflows
- Mitigate signals and actions with clinical data scientists
- Perform data cleaning oversight
- Process study data for signal and action management
- Review protocols for setup review reporting requirements
- Review system outputs for signal and action management
- Set up and test RBM system
- Set up data quality assessment dictionary
- Set up key risk indicators
Perks/Benefits
- N/A
Skills/Tech-stack
Action Management | CRF design | Clinical Trial Protocol Review | Clinical trial | Clinical trial database | Clinical trial protocol | Data Management | Data Quality | Data cleaning | Data quality assessment | Database Design | Database Programming | Database setup | Dictionary Setup | Edit Check | Edit Check Specification | ICH GCP | Issue Resolution | Java | Key Risk Indicators | Microsoft Excel | Microsoft PowerPoint | Microsoft Project | Microsoft Word | Oracle | PLSQL | Project Management | Protocol review | Quality Assessment | Relational Database | Relational Database Design | Risk indicators | Risk-Based Monitoring | Risk-based | SAS | SOP compliance | Signal management | Windows
Education
Bachelor of Engineering | Bachelor of Science | Master of Science | PhD
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