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Trial Manager (Internal/External Trials)

Summary

Salary
Competitive
Team
Compliance and approvals
Location
Malmesbury - United Kingdom

About us

Dyson is a global technology enterprise. We solve the problems others choose to ignore, with surprising new inventions that defy convention and simply work better. We’re driven by progress and thrive on the challenge of relentless improvement. We’re growing fast and our ambition is huge – more categories, more locations and more people.

About the role

The Trials Lead will be ‘hands on’ and fully involved in all aspects of the human subject trials within the company and manage external clinical trials when required. The Trial Lead will be responsible for all aspects of the human subject trials with medical devices within the company from trial plan, risk assessment, safety approval, volunteer recruitment, maintaining provision of trial supplies including the trial devices, trial conduct, analysis and reporting. The internal company trials would be of a sensory/consumer testing nature. 
The primary role of the successful candidate will be to manage the internal trials. The management of the external company sponsored clinical trials within Europe from a clinical operations perspective from clinical site selection and assessment through SIV, study conduct, and study close out including monitoring of the clinical trials would be required as well. The ideal candidate has clinical and/or research experience in a multidisciplinary setting (Industry or CRO). Knowledge of and experience within medical device industry is desirable. 
The post requires drive, a pro-active attitude, and attention to detail. The successful candidate can look forward to being part of an ambitious, cohesive, and multidisciplinary team working hard to achieve the development of novel products. The role benefits from growth opportunities within the Clinical Affairs function as the function is being developed.

Key Responsibilities of the Trial Lead:

Internal Trial Management:
  • Co-ordinate consumer testing, including trial design, interfacing with internal safety review boards (application and approval); and data (safety and privacy) management.
  • Contribute to the consumer testing design and assessment technologies.
  • Provide general administrative support to Clinical Affairs function and assistance to Project Managers and Project Team.
  • Manages the timeline and project deliverables.
  • Assist in completion of all required tasks to meet departmental and project goals.
  • Assist with compiling trial data that will contribute to reports based on this research.
  • Assist in the development and implementation of recruitment strategies to increase trial participant recruitment.
  • Draft and/or assist with preparation of trial-related documents and procedure manuals, source documents, tools and templates (start-up forms, study logs)
  • Manage trial site files and manage trial participant queries for the research studies.
  • Co-ordinate trial participant visits according to the trial protocol.
  • Co-ordinate pre-trial medical questionnaire for participants.
  • Assist project teams with study specific documentation including Risk assessments, Trial protocols, Questionnaires, Reports, Review documents etc.
  • Set up, organize and maintain trial documentation including preparation for internal reviews and archival.
  • Process data collection forms i.e. Questionnaires
  • Co-ordinate ordering/dispatch and tracking of trial materials as appropriate.
  • Assist project teams with trial progress tracking by updating the Project time-plans.
  • Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
  • Assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

External Trial Management:
  • Manage all aspects of external company-sponsored clinical trials within Europe from clinical site selection and assessment through SIV, study conduct, and study close out including monitoring of the clinical trials.
  • Assist project teams with study specific documentation and guidelines as appropriate.
  • Set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
  • Process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
  • Assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).
  • Co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies) as appropriate.
  • Assist project teams with trial progress tracking by updating the Clinical Trial Management systems.
  • Copy and route incoming correspondence, internal documentation, CRFs, etc., as appropriate.
  • Assist in co-ordination of Investigator payments, if applicable.
  • Contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).
  • Assist in the tracking and distribution of safety reports.
  • Co-ordinate document translation, if required.
  • Attend project team meetings and generate meeting minutes.
  • Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation and generate meeting minutes.
  • Selected sites conduct and deliver the trial according to the clinical trial protocol, within-trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
  • To be familiar with ICH GCP, appropriate regulations, relevant company SOP’s and company internal tracking systems. All duties must be performed to Good Clinical Practice standards as laid out by the International Conference on Harmonisation.


About you


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable training will be made available to enable individuals to perform the essential functions. 
  • Bachelor’s degree in a scientific or health field, or equivalent experience in clinical research/medical environment.
  • At least 3 years of relevant experience in clinical research preferably in medical device/CRO industry.
  • Clinical Research/Operations work experience essential. 
  • Chemical and Biological Safety Assessment skills preferable.
  • Detail and quality oriented. 
  • Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.
  • Good written and verbal communication skills.
  • Good written and spoken English.
  • Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook
  • Occasional travel to conduct site visits/vendor audits etc.


Benefits

  • 27 days holiday plus eight statutory bank holidays 
  • Pension scheme
  • Performance related bonus
  • Life assurance
  • Free on-site parking
  • Subsidized café
  • Discounts on Dyson machines
  • Private Medical and Dental

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Interview guidance

We are following the government guidelines regarding COVID19. At this time all interviews will be conducted via video or telephone. We’re taking these precautionary measures to protect both our employee and candidate wellbeing. Our Talent Acquisition team will work with you and provide further information as appropriate.