Terumo Aortic have an exciting opportunity for a Clinical Study Manager on a Fixed Term Basis for 12 months. 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 the execution, management and closeout of Clinical Affairs studies or assigned part of study.
• Ensure data quality.
• Write, submit, and circulate progress reports within specified timelines.
• Develop and implement Clinical Investigation Plan and associated essential documents.
• Participate in the selection of CRO/vendor and manage CRO/vendor.
• Ensure the timely receipt, assessment, and reporting of Adverse Events arising from Clinical Trials and Post Market Clinical Follow-up Studies/Registries in line with the quality management system and regulatory requirements.
• Trending, presentation, and circulation of Adverse Event data.
• Maintain Trial Master Files.
• 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 contracts.
• Responsible for the oversight of all monitoring activities.

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.
• 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.
• Demonstrated ability to deliver results to the appropriate quality and timeline metrics.