
Clinical Data Governance Manager
4 days ago
The Central Data Quality Leader plays a vital role in ensuring data accuracy, integrity, and compliance across clinical development programs. This leader is accountable for developing enterprise-wide quality management strategies and overseeing the design and implementation of centralized statistical monitoring frameworks.
Key Responsibilities:
- Develop Comprehensive Quality Plans: Collaborate with cross-functional teams to design and implement comprehensive quality plans tailored to each study's needs.
- Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
- Advanced Statistical Monitoring: Design and oversee the implementation of advanced statistical monitoring frameworks.
- Quality Meetings: Lead facilitation of regular quality meetings to review and discuss study data, findings, and action plans.
- Data Assurance and Oversight: Ensure the highest standards of data quality and integrity through proactive monitoring and timely interventions.
Qualifications:
- Bachelor's Degree in a relevant field (life sciences, statistics, data management)
- Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent
- Working knowledge of ICH GCP guidelines and the clinical development process
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