Permanent
 Clinical Risk Advisor
 Inchinnan

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Senior Clinical Risk Advisor

Ref: 287| Posted: 5th Feb 2025

Terumo Aortic is currently recruiting for a Senior Clinical Risk Advisor to join our team on a 12-month fixed-term contract. The successful candidate will be responsible for implementing the global clinical strategy set by the Global Vice President of Clinical and Medical Affairs. This role aims to develop consistent clinical standards across all key markets, ensuring alignment with global clinical practices and the company’s business plan.

Key Duties;

  • Create internal Clinical Risk documents and procedures as required
  • Support the implementation of the Clinical Risk strategy for internal Clinical Risk documents
  • Work closely with internal departments to develop, review and sign-off technical documentation
  • Work closely with the Quality Assurance department to develop, review and sign-off of documents including (but not limited to) Benefit-Risk Analysis and Health Risk Assessments
  • Provide Clinical Governance oversight and work with other departments to understand requirements for Clinical Governance within the business to ensure the appropriate standard is being met
  • Maintain awareness and knowledge of current and relevant medical practice
  • Consult and present to individuals and groups on behalf of Terumo Aortic where appropriate
  • Attends seminars, symposia and special events as required
  • Clinical input into the complaints process for reportability decisions
  • Clinical input into clinical trial protocols as required
  • Review AE and SAE trends for pre-and post market clinical studies
  • Help maintain the Facility Harms List, to help assure the validity of the defined harms and related severities and judge harm severity appropriately
  • Attend the Complaints Review Board (CRB) and the Action Review Board (ARB) as required
  • On-board and mentor Clinical Risk Advisors
  • Other tasks as deemed necessary by the business

Qualifications & Experience;

  • BSc degree, or equivalent Nursing Qualification (Essential)
  • Current clinical professional membership (Essential)
  • Experience in working within a quality management system (Desirable)
  • Experience in Clinical Governance (Desirable)
  • Experience in clinical research (Desirable)
  • Experience in the audit process (Desirable)
  • Previous medical device experience (Desirable)
  • Management experience (Desirable)