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1 week ago
This role drives data integrity, patient safety, and operational excellence through advanced centralized monitoring and risk-based quality management (RBQM).
Key Responsibilities:
- Lead the development of RBQM plans in collaboration with cross-functional teams.
- Conduct thorough risk assessments for clinical studies and develop mitigation strategies.
- Design and oversee the implementation of advanced centralized statistical monitoring frameworks.
- Facilitate monthly RBQM meetings to review study data, findings, and action plans.
- Ensure high standards of data quality and integrity through proactive monitoring and timely interventions.
Qualifications:
- Bachelor's Degree in a relevant field or equivalent combination of education, training, and experience.
- Minimum 8 years of experience in clinical monitoring, clinical trial management, or equivalent.
- Working knowledge of ICH GCP guidelines and the clinical development process.
This role requires strong leadership, analytical, and problem-solving skills, as well as excellent communication and organizational skills. The ideal candidate will have a deep understanding of RBQM principles and methodologies.
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