Clinical Trial Quality Manager Job Summary
">Overview: A clinical trial quality manager is a critical role that involves overseeing the implementation of quality management systems in clinical trials. This individual will contribute to the development of procedures, tools, and resources necessary for effective quality system management.
">Responsibilities:
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* Contribute to the development of area-specific procedures, tools, and resource documents.
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* Review and approve content (as assigned) of quality system documents.
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* Ensure regional and/or affiliate quality system requirements have clear accountabilities.
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* Recommend new quality system documents or changes to existing ones where applicable.
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* Advise on appropriate training for implementation and documentation.
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* Consult on interpretation and practical application of external requirements, standards, and procedures.
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* Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
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* Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
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* Provides input into risk assessments, audit planning, and/or quality plans based on identified signal/risks/gaps.
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* Complete self-inspections and drive improvements that are meaningful and actionable.
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* Ensure local implementation of the quality systems as necessary.
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* Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
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">Requirements:">
* Bachelor's Degree in a science/technology/health care related field or equivalent work experience.
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* Demonstrated ability to apply quality systems within a regulated work environment.
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* Experience in a quality control/quality assurance role.
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* Experience in defined functional business areas (e.g., medical writing, regulatory affairs, or clinical trial management).
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* Effective project and time management skills.
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* Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
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* Demonstrated ability to prioritize and handle multiple concurrent tasks.
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* Strong interpersonal skills with demonstrated flexibility in varying environments/geographies.
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* Effective organization/self-management skills.
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* Ability to work independently and as part of a team.
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">For more information, please contact Sinéad Cullen on +353879500821.