Clinical Research Manager

Vascutek Terumo

Inchinnan, Glasgow, United Kingdom

Position Description

Vascutek required an experienced and enthusiastic individual oversee the development, set up and management of clinical studies and post market surveillance studies/registries within the company.

Key responsibilities and duties will include:

  • Manage a team of Clinical Study Managers;
  • Develop and implement new medical device clinical studies as required by the company’s product pipeline;
  • Manage clinical studies in line with GCP, ISO 14155 and other relevant regulations;
  • Responsibility for clinical study budgets;
  • Responsible for patient recruitment and compliance of all clinical studies;
  • Discuss clinical study activities with KOLs;
  • Oversee day to day actions of the clinical studies team, delegating and prioritising tasks;
  • Prepare and submit medical device clinical study documentation for regulatory approval;
  • Communicate with relevant parties (internal and external);
  • Mentor and develop direct reporting staff;
  • Maintain and support the on-going development of appropriate systems and procedures within the department;
  • Manage multiple projects and activities simultaneously.

Required Experience:

  • Qualified to degree level or equivalent professional qualification in a relevant application;
  • Proven experience of working in a similar role;
  • Experience of both pre and post-market Clinical Studies of medical devices;
  • Experience in managing and mentoring a team;
  • Solid knowledge of GCP and ISO 14155;
  • Awareness of the relevant regulations and country-specific clinical study requirements;
  • Experience of vendor management (CROs, Core Lab, EDC suppliers etc);
  • Proven ability in clinical study set-up and management;
  • Experience of writing clinical study reports and submission documentation;
  • Prior experience of dealing with Competent Authorities and ethics committees for clinical studies;
  • Experience of working in a quality system environment;
  • Excellent record of documentation management;
  • Proven experience in using Microsoft Word, Excel, Project and PowerPoint.

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