Manager, Clinical Quality and Compliance
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Job Description
Manager Clinical Quality and Compliance overseeing quality management and regulatory adherence at Dexcom. Collaborating cross-functionally to drive clinical quality initiatives and improve patient safety.
Responsibilities:
- Promote a culture of quality.
- Manage clinical safety oversight.
- Implement measures to ensure product quality and patient safety.
- Champion continuous improvement initiatives.
- Review and approve clinical study protocols.
- Lead the review and management of post-market clinical follow-up activities.
- Develop and implement vendor qualification processes.
- Lead or support internal and external audits as required.
- Develop and maintain quality procedures and work instructions.
- Lead the CAPA process, including investigation, root cause analysis, and implementation of corrective/preventive actions.
- Review and approve validation protocols and reports.
- Collaborate with cross-functional teams to address quality-related issues and drive improvements.
- Oversee the management of the electronic trial master file system.
Requirements:
- Experience working in clinical research and knowledge of clinical trial design and analysis.
- Minimum of 3 years in Clinical Quality role.
- Experience in audit support.
- Excellent communication and presentation skills, with the ability to communicate results and insights to non-technical stakeholders.
- Ability to work independently and collaboratively in a team environment.
- Familiarity with continuous glucose monitoring devices and diabetes management is a plus.
Benefits:
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
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