Permanent
 Clinical Study Manager
 Inchinnan

Apply

Clinical Study Manager

Ref: 274| Posted: 8th Nov 2024

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.