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Clinical Trial Monitor

  • Job reference: 924812
  • Location: Leeds, West Yorkshire
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 10/04/2019

Orion Group are looking for a Clinical Trial Monitor for our multinational medical devices client based in the West Yorkshire area on an initial 12 month contract.

Main Responsibilities of the role:

  • Provide support to Clinical Trial Leader for agreed projects in the EMEA Clinical Research programme for the defined therapeutic area by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.
  • Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well-being of all trial participants and good/rigorous scientific practice.
  • Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions for the approval of clinical investigations to regulatory authorities and ethics committees.
  • Keep abreast of developments in clinical research and the clinical literature in therapeutic areas of responsibility.
  • Assist in the preparation of consent documentation where required for the proper scientific evaluation of new or existing products in accordance with all ethical and regulatory requirements for Medical Devices in respect of applicable European and International Medical Devices Regulations.
  • Monitor defined clinical studies in accordance with Good Clinical Practice requirements and provide regular feedback to company personnel on the progress of trials.
  • Administer the inventory of Investigational Products and control the issue of investigational products to approved sites where necessary.
  • Participate in project teams and build relationships with investigators, regulatory bodies and appropriate company personnel as required regarding clinical research issues, working as directed by Clinical Trial Leader & monitoring team.
  • Maintain compliance with Company SOPs.
  • Maintain a high standard of housekeeping and filing accuracy.

Desired background and Experience of the successful candidate

  • a) Knowledge: 1. Minimum Education Requirements:
    1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.
  • 5+ years' experience of clinical trials monitoring in a medical company preferably with medical devices.
  • Knowledge of clinical study design and management. Relevant experience in implementation of clinical research studies. Working knowledge of international regulatory requirements applicable to clinical research. Awareness of research ethics. Above average oral, written and communication skills.
  • Problem Solving: Independent judgement is employed in problem solving for project management with supervision.
  • Decisions are made subject to established company, departmental and government policies and regulations with supervision.
  • Degree of Responsibility: Instrumental in meeting departmental objectives. Must be highly responsible and capable of seeing each project to its conclusion.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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Clinical Project Manager
  • Salary Negotiable
  • Job type Contract
  • Location Leeds, West Yorkshire
  • Description Orion Group are looking for a Clinical Project Manager for our multinational medical devices client based in the West Yorkshire area on an initial 12-month contract with the potential to extend