Clinical Development Expert
1 week ago
The Principal Central Monitor plays a pivotal role in ensuring data integrity and patient safety across clinical development programs through advanced centralized monitoring. This strategic leader collaborates with senior functional leaders to shape enterprise-wide quality management strategies.
Key Responsibilities:
- Develop comprehensive risk-based quality management plans, collaborating with cross-functional teams to design tailored strategies.
- Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies.
- Design and oversee the implementation of centralized statistical monitoring frameworks, interpreting complex data patterns and leading root cause analyses.
- Facilitate regular quality management meetings, bringing together key stakeholders to review study data, findings, and action plans.
- Maintain the highest standards of data quality through proactive monitoring and timely interventions.
Requirements:
- Bachelor's Degree in life sciences or equivalent combination of education, training, and experience.
- Minimum 8 years of experience in clinical monitoring or clinical trial management.
- Working knowledge of ICH GCP guidelines and the clinical development process.
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