Director Integrated Data Quality
Tasks
- Define integrated data review strategy
- Develop SOPs work instructions and templates
- Develop standardized data review plan methodologies
- Drive continuous improvement of IDR methods
- Ensure adoption across clinical study teams
- Ensure execution of data review plans
- Establish governance framework
- Identify data quality risks
- Implement mitigation strategies
- Lead change management and training
- Maintain standardized data review output libraries
- Oversee data review execution with KPIs
- Translate risk based data management to review approaches
Perks/Benefits
- 401k company match
- Family support benefits
- Fitness centers
- Health and wellness programs
- Insurance benefits
- On-site work 4 days a week
- Paid time off
- Travel 10 percent
Skills/Tech-stack
21 CFR | 21 CFR Part 11 | By Design | CFR Part 11 | Centralized monitoring | Change Management | Clinical data | Clinical data management | Critical to quality | Data Management | Data Quality | Data Quality Management | Data Review Governance | Data Trends Analysis | Data review | Data review plans | Data trends | Governance models | GxP | ICH E6 | ICH E6 R3 | ICH E8 | ICH E8 R1 | Integrated Data Review | KPI Development | Part 11 | Quality by Design | Quality management | Quality metrics | Review Governance | Risk Based Data Management | Risk-Based Quality Management | Risk-based | Risk-based quality | SOP Development | Trends Analysis
Education
N/A
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