Sr. Manager, Med Device Clinical Audits/QA (Remote)
Position Overview
Responsible for planning, coordinating, and managing clinical audits, monitoring departmental due diligence activities; and developing clinical research systems and processes. Responsible for overseeing the planning and implementation of clinical research studies in compliance with company, ICH/GCP, company SOP’s, and applicable regulatory requirements. When applicable, assist in filing compliance reports with regulatory bodies. Job duties:
- Ensure all processes of a clinical trial are conducted properly.
- Collaborate with cross-functional groups including, but not limited to, Regulatory, Quality, and complaint handling to ensure Clinical Operations adherence to company policies and regulations.
- Keep up to date with all related quality legislation and compliance issues and perform gap analysis and remediation strategy to implement within internal systems.
- Conduct and/or oversee internal and external auditing activities to ensure studies are conducted in accordance with sponsor protocols, GCP/ICH/ISO, industry guidelines, and agency regulations.
- Create quality risk management plan, audit schedules, and BIMO readiness plans for current clinical studies.
- Communicate any critical compliance risks noted from these activities to senior management.
- Manage the tracking and resolving of procedure, GCP and/or ISO deviations and manage Corrective Action/Preventative Action (CAPA) investigations.
- Ensure timely issuance of audit reports, audit observation forms, oversee audit response process, and drive audits to closure.
- Act as the key contact representing the company on contracts or projects, including inter-departmental teams.
- Assist the clinical teams in the execution of clinical trials.
- Assist in data authentication and document reviews for, but limited to, protocols, informed consents, clinical study reports, investigator brochures, regulatory submission documents, and other essential study documents as assigned.
- Develop risk based CQA infrastructure (e.g., SOP, job descriptions, etc.) and manage and develop staff.
- Manage special projects and perform additional duties as assigned.