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2 weeks ago
This is a leadership position that drives data integrity, patient safety, and operational excellence across clinical development programs through advanced centralized monitoring and risk-based quality management.
Main Responsibilities:- Data Integrity – Drive the development and execution of enterprise-wide RBQM strategies
- Risk Assessment – Lead complex risk assessments and define key risk indicators (KRIs)
- Monitoring Frameworks – Design and implement centralized statistical monitoring frameworks
- Collaboration – Collaborate with cross-functional teams to support study deliverables
- Bachelor's Degree in a relevant field or equivalent combination of education and experience
- Minimum 8 years experience in clinical monitoring, clinical trial management or equivalent
- ICH GCP Guidelines – Working knowledge of ICH GCP guidelines and the clinical development process
- CRO experience as a Central Monitor
The ideal candidate will have a strong understanding of RBQM principles and methodologies, excellent communication and organizational skills, and proficiency in statistical analysis and data monitoring tools. This role requires strategic thinking, collaboration, and problem-solving skills to drive data integrity and patient safety across clinical development programs.
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