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