Terumo Aortic have an exciting opportunity for a Clinical Study Manager to join our team during a phase of growth and investment. The successful individual will be responsible for the development, set-up, and maintenance of clinical trials and Post Market Clinical Follow-up Studies.

Key Duties

• Work in compliance with ICH GCP, the Medical Device Regulations, ISO 14155, internal procedural documents, and any other relevant regulatory requirements
• Responsible for all aspects of the set-up, execution, management, and closeout of assigned Clinical investigations or PMCF studies
• Provide cross-functional oversight of internal project team members and deliverables, which includes ensuring all necessary project-specific training is provided
• Ensure data quality and maintenance of Trial Master File
• Lead the selection, set-up, and management of CRO/vendor(s)
• Develop and implement Clinical Investigation Plan, Investigator Brochure, Case Report Forms, and other associated essential documents.
• Develop, implement, and maintain study project plans
• Oversee and provide input to clinical database development, edit check specifications, data analysis plan, and final study report, when applicable
• Prepare and manage clinical study risk assessment and execution
• Preparation and management of regulatory and ethical submissions
• Manage site quality, including vendor Clinical Research Associates and monitoring deliverables
• Write, submit, and circulate progress reports within specified timelines
• Ensure the timely receipt, assessment, and reporting of Adverse Events in line with the quality management system and regulatory requirements
• Process data requests from internal personnel and external parties
• Communicate with customers both verbally and in writing as required
• Presentation of study/registry data and results (internally or within the extended team)
• Prepare and coordinate contract and budget negotiations with vendors and sites

Qualifications and Experience

• Bachelor’s degree or equivalent in a related field or equivalent combination of education, training and experience.
• Proven experience in a similar Clinical Studies role within a medical device or pharmaceutical environment.
• Experience in leading Pre-market clinical investigation either Globally, Europe or US
• Solid knowledge of GCP and ISO 14155.
• Awareness of the relevant regulations and country-specific clinical study requirements.
• Experience in monitoring clinical studies.
• Experience in writing clinical study reports and submission documentation.
• Proven experience in using Microsoft Word, Excel, and PowerPoint.
• Experience in utilisation of a CTMS and/or eTMF
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.