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Clinical Study Manager

  • Job reference: 925583
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Contract
  • Sector: R&D - Clinical & Non Clinical, Life Sciences
  • Date posted: 22/05/2019

SUMMARY OF POSITION:

Provide support to the implementation of the clinical research operations programme for the Clinical Operations Franchise in accordance with all applicable regulations for Medical Devices. Plan & implement a programme of study management for post-market surveillance clinical research studies and maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants, and good/rigorous scientific practice.

JOB SPECIFICATIONS

  1. a) Knowledge: Minimum Education Requirements:

1st Degree in Life Sciences, Health Sciences or related field to Biomedical Engineering or equivalent combination of education and experience.

  1. Minimum Experience Requirements:

Minimum 4 years' experience of clinical trials management in a medical company preferably with medical devices.

  1. Minimum Skill Requirements:

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.

  1. Equipment or Machines Used:

Personal computer and general office equipment.

  1. Problem Solving: Independent judgement is employed in problem solving for project management.

  1. Decision Making: Decisions are made subject to established company, departmental and government policies and regulations with supervision.

  1. Degree of Responsibility: Instrumental in meeting departmental objectives. Must be highly responsible and capable of team management in seeing each project to its conclusion.

  1. Extent of Confidentiality: Access to and knowledge of technical, clinical, and regulatory data on many products including adverse event data. Limited access to the research programmes, strategy and commercial data of other affiliates. Limited contact with competition, Government and Regulatory Bodies in situations where discretion and security are critical. Access to confidential clinical information and medical history of patients entered into clinical research programmes.

  1. f) Interpersonal Contacts: Medical, health care and academic institutions e.g. Consultants, Senior Nursing staff and Heads of Department together with their teams. Hospital and Regional Ethical Committees. MHRA and other Competent Authority staff. Patients during clinical investigations. Clinical research and regulatory organisations. Competition through professional societies, meetings and conferences.

  1. g) Adverse Work Environmental

Conditions: Some visits to hospitals.

  1. Physical

Frequent travel to Inverness, UK.

KEY TASKS

  1. Provide support to Clinical Operations for agreed projects by monitoring and reporting on studies progress in accordance with all Corporate and Statutory requirements to agreed timescales.

  1. Maintain the highest ethical, clinical and scientific standards ensuring both the safety and well being of all trial participants and good/rigorous scientific practice.

  1. Keep abreast of international legislation and other requirements concerning clinical research. Prepare and submit submissions or amendments for the approval of clinical investigations to regulatory authorities and ethics committees.

  1. Responsible for the oversight of a variety of medical device studies conducted on a continual basis at sites across the UK.

  1. Project management of multiple studies in parallel, ensuring day to day oversight of tasks, coordination of resource and tracking actions in relation to study conduct, data management, equipment and supplies management.

  1. Responsible for maintaining all appropriate comms as per communication plan including creation of site Newsletter and collation of site performance metrics.

  1. 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 Operations team management.

  1. Maintain compliance with Company SOPs.

  1. Maintain a high standard of housekeeping and filing accuracy.


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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