Clinical Trial Quality Lead
This key role in a client’s Medicines Quality Organisation team is responsible for ensuring the quality of clinical trials.
* Develop procedures and required tools, resource documents, and supplemental materials specific to clinical trials.
* Review and approve quality system documents to ensure they meet regional and/or affiliate quality system requirements.
* Advise on training for implementation and documentation, as well as provide consultation on external requirements, standards, and procedures.
* Oversee deviations, change controls, notification to management, root cause analysis, and corrective/preventive actions.
* Provide input into risk assessments, audit planning, and quality plans based on identified signals, risks, or gaps.
* Complete self-inspections and drive improvements that are meaningful and actionable.
* Evaluate local implementation of quality systems as necessary.
* Support management of external parties, such as third-party organizations or business alliance partners.
Required Skills and Qualifications
* Bachelor's Degree in a science, technology, or healthcare-related field or equivalent work experience.
* Demonstrated ability to apply quality systems within a regulated environment.
* Experience in a quality control/quality assurance role.
* Defined functional business areas, such as medical writing, regulatory affairs, or clinical trial management.
* Effective project and time management skills.
* Ability to communicate effectively and influence others.
* Capacity to prioritize and handle multiple concurrent tasks.
* Strong interpersonal skills with flexibility in varying environments/geographies.
* Effective organization/self-management skills.
* Ability to work independently and as part of a team.