Senior Clinical Trial Operations Specialist
1 day ago
Clinical Trial Quality Professionals work with pharmaceutical organisations to ensure the quality of clinical trials. This role requires experience in Clinical Trials and Quality Management Systems.
- Develop area-specific procedures, review and content approve quality system documents, and ensure regional quality system requirements have clear accountabilities.
- Recommend new quality system documents or changes to existing ones where applicable.
- Advise on training for implementation and documentation.
- Consult on external requirements, standards, and procedures.
- Manage deviations, change controls, Notification to Management (NTM), and ensure events are documented, escalated, and completed.
- Lead root cause analysis and corrective/preventive actions (CAPA).
- Provide input into risk assessments, audit planning, and quality plans.
- Complete self-inspections and drive improvements.
- Ensure local implementation of quality systems.
- Support external party management.
Key Qualifications
- Bachelor's Degree in a science, technology, or healthcare-related field or equivalent work experience.
- Ability to apply quality systems within a regulated work environment.
- Experience in quality control or quality assurance roles.
- Defined functional business areas experience, such as medical writing, regulatory affairs, or clinical trial management.
- Effective project and time management skills.
- Strong communication and interpersonal skills.
- Ability to prioritize and handle multiple tasks.
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