INNOVATION THROUGH PEOPLE
Are you interested in working for an organization that is making a difference in people’s lives every day? We’re a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We’re a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technological advanced products supported by proven clinical data. Take a closer look at what MicroVention® TERUMO has to offer.
The Clinical Quality Compliance (CC) Project Manager plays a key role in the delivery of the GCP/ICH/ISO audit program to ensure compliance with federal regulations and local regulatory authorities regulations, policies and procedures. The successful candidate will represent the company both internally and externally. The CC Project Manager will participate in planning, coordinating, and conducting audits, monitoring, and due diligence activities as well as overseeing and managing other CC Specialist(s) or auditor(s). The audit process will include identifying compliance issues that require formal attention and developing risk management strategies to avoid non-compliance. When applicable the CC Project Manager will assist in filing compliance reports with regulatory bodies.
The CC Project Manager should be well-versed in federal regulations, demonstrate Good Clinical Practices (GCP), International Conference on Harmonization (ICH), International Organization for Standardization (ISO) where applicable, as well as internal policies, and procedures. The Clinical Quality Compliance (CC) Project Manager reports to the Associate Director, Clinical Research. Typical job duties might include:
- Ensuring that all processes contributing to the performance of a clinical trial are conducted properly.
- Keeping up-to-date with all related quality legislation and compliance issues.
- Utilizing guidance documents, international standards, and/or consensus standards.
- Conducting document reviews and audits of protocols, informed consents, clinical study reports, investigator brochures, regulatory submission documents, and other essential study documents as assigned.
- Leading auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP/ICH/ISO, industry guidelines, and agency regulations.
- Conducting audits of clinical investigator sites, vendors, databases, facility and clinical laboratories, systems and processes.
- Manage and oversee compliance specialist and/or consulting auditors with auditing activities.
- Working closely with Clinical Operations, Regulatory, Data Management, Quality, Information Technology, and other supporting areas/development teams.
- Communicating any critical compliance risks noted from these activities to senior management.
- Assisting in tracking and resolving SOP, GCP/ICH and/or ISO deviations and manage Corrective Action/Preventative Action (CAPA) investigations.
- Ensuring timely issuance of audit reports, audit observation forms, oversee audit response process and drive audits to closure.
- Performing other duties as assigned.