Clinical Study Manager
Terumo Aortic
Date: 5 hours ago
City: Renfrew
Contract type: Full time
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
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.
- 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.
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