Senior Clinical Quality Specialist
5 days ago
This role plays a pivotal part in ensuring the delivery of high-quality services.
The Quality Assurance & Compliance Manager is responsible for leading and facilitating activities to enhance quality in project delivery. They work closely with all business units to identify, analyze, and rectify systemic quality issues in clinical delivery that are country-specific in origin.
Key Responsibilities:- Provide guidance and support to project teams for CAPA development and tracking.
- Monitor available KPI/Metrics reports across the BUs and identify common tendencies/issues for quality improvement at a local level.
- Support project teams in communicating and managing complex quality issues with the sponsor and/or with sites. Mentor junior staff members if applicable.
- Identify country-specific training needs across the BUs and work with global and local stakeholders to provide required solutions.
- Bachelor's degree in science or healthcare, or equivalent combined education and experience.
- Moderate clinical research experience in Pharma/CRO/Site Management preferred.
- Knowledge of ICH GCP, JGCP or In-country equivalent required.
- Ability to act independently and proactively on personnel management, customer management, and project management.
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