Clinical Trial Quality Lead
Our organization is seeking a seasoned professional to fill the role of Clinical Trial Quality Lead. The ideal candidate will have extensive experience in clinical trials and quality management systems, with a proven track record of driving quality initiatives and improving processes.
Key Responsibilities
* Develop area-specific procedures and tools, including review and content approval of quality system documents.
* Recommend new quality system documents or changes to existing ones where applicable.
* Advise on training for implementation and documentation.
* Provide consultation on interpreting and applying external requirements, standards, and procedures.
* Responsible for deviations, change controls, and ensuring events are properly documented, escalated, and completed.
* Consult on root cause analysis and corrective/preventive actions (CAPA).
* Provides input into risk assessments, audit planning, and quality plans based on identified signals, risks, and gaps.
* Complete self-inspections and drive improvements that are meaningful and actionable.
* Ensure local implementation of quality systems as necessary.
* Support external party management as assigned.
Requirements
* 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/quality assurance roles.
* 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.
* 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.
For more information, please contact us at +353879500821 or sinead.cullen@lifescience.ie.