Role Description
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.