Clinical Study Manager

Clinical Study Manager

Ref: 163| Posted: 1st Jun 2023

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.