Senior Manager R&D Quality Analytics & Portfolio Insights
Tasks
- Analyze adverse event reporting signals
- Build predictive models and decision support tools
- Conduct cross study and portfolio risk analysis
- Conduct source to report reconciliation
- Coordinate analytics workstreams end to end
- Create executive ready visualizations and recommendations
- Develop analytical approaches for audit planning
- Develop quality indicators and thresholds
- Develop statistical packages and dashboards
- Identify emerging quality risks
- Integrate clinical and safety data for oversight
- Maintain analytics governance documentation
- Perform data cleaning and transformation
- Perform data profiling and mapping
- Perform root cause analysis
- Support GLP and GCLP oversight analytics
- Support GVP safety reporting analytics
- Support RBQM and quality by design governance
Perks/Benefits
- N/A
Skills/Tech-stack
APIs | Access Controls | Anomaly Detection | By Design | Change Management | Cloud Platforms | Data Lineage | Data Mapping | Data Pipelines | Data Reconciliation | Data Transformation | Data Warehousing | Data cleaning | Data profiling | ELT | ETL | Explainability | Forecasting | GCLP | GCP | GLP | GVP | Generative AI | Git | Language Processing | Machine Learning | Natural Language | Natural Language Processing | Performance Monitoring | Power BI | Predictive Modeling | Python | Quality by Design | Quality management | R | Risk-Based Quality Management | Risk-based | Risk-based quality | SQL | Statistics | Validation | Version control
Education
N/A
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