Skip navigation

Have you considered using our job search? Click here to search our current jobs.

Have you considered using our job search? Click here to search our current jobs.

Lead Clinical Research Associate

Summary

Salary
Competitive
Team
Science and Research
Location
United Kingdom - Malmesbury Office

About us

Dyson is globally recognised as a pioneering and research-oriented engineering company. With a focus on consumer healthcare products within Dyson, a new Medical & Clinical Affairs function and team is being developed internationally with a clear focus on innovation and research.  

 
Medical Affairs serves as the scientific bridge between the industry and the wider medical community. This function is uniquely tasked with managing external relationships with key opinion leaders within the scientific community across a range of therapeutic specialisms, as well as with patient-consumer groups, authorities and beyond.


Clinical Affairs are experts in clinical research and by integrating into an innovative engineering company, focus is on designing new methodologies and gathering essential evidence to drive new product category growth. 


We have a common vision of improving the quality of life of consumers through pioneering medical engineering in a safe and compliant way throughout the entire product lifecycle.
 

About the role

The Lead Clinical Research Associate (LCRA) is a hybrid role of managing Internal User Trials in the United Kingdom campus and External Global Clinical Trials. The LCRA will also monitor the progress of clinical studies at investigative sites, internally or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

The LCRA will be ‘hands on’ and fully involved in all aspects of the clinical trials to manage external company sponsored clinical trials and internal consumer testing trials when required at the Dyson United Kingdom campus. LCRA will be responsible for all aspects of the human subject trials 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. 


Key Responsibilities:

User Trial Management - Internal:

  • 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.

  • Assist with compiling trial data that will contribute to reports based on this research.

  • Manage trial site files and manage trial participant queries for the research studies.

  • Process data collection forms i.e., Questionnaires

  • Co-ordinate and process pre-trial to end trial required procedures according to company and department processes and trial protocol. 

  • Set up, organize and maintain trial documentation including preparation for internal reviews and archival.

Global Clinical Trial Management – External:

  • Assesses the qualification of potential sites/CROs, initiates clinical trials at sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at sites.

  • Develop clinical trial site capabilities globally including Asia, Europe and Americas.

  • Participate in clinical trials related activities and assist in management of clinical study sites, management of study documentation, and completion of project management tasks.

  • Prepare and maintain Clinical Study Files - Trial Master Files such as but not limited to Investigator Site File, study essential documents and regulatory documents.

  • Work with sites to prepare Ethics Committee and Regularity Authorities (if applicable) documents for submission and other tools, templates and documents before clinical site initiation.

  • Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.

  • Maintain effective working relationships with site, investigators, research coordinators, and vendors including core labs, data management, and CROs.

  • Liaise closely with a multidisciplinary team to coordinate pilot production of new products.

  • Set up, organize and maintain trial documentation including preparation for internal reviews and archival.

  • 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.

  • 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 


The ideal candidate is very experienced in clinical and research experience in a multidisciplinary setting (company 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.

  • 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. 

  • Degree in Biology, Life Sciences, Biotechnology or equivalent

  • Demonstrated a wide range of experience in industry of clinical affairs/clinical development/clinical research experience with in-depth knowledge of ICH GCP.

  • Experience in medical device industry is at added advantage. 

  • Occasional travel to conduct site visits/vendor audits etc.

  • Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

  • Excellent interpersonal skills, presentation skills and the ability to work well and autonomously, in small teams and with a wide range of varying stakeholders.

  • Good written and spoken English.

  • Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook, MS Project

At Dyson we believe that being different and authentic helps us to pioneer together. Please let us know if you require any adjustments or accommodations to enable you to be your authentic self at Dyson.

Benefits

Financial: 

  • Performance related bonus 

  • Company paid Life Assurance 

  • Discounts on Dyson machines 

  • Competitive pension scheme 

  • Purchase additional holidays  

Lifestyle: 

  • 27 days holiday plus statutory bank holidays 

  • Free bus travel to and from Malmesbury campus from Bristol, Chippenham and Swindon 

  • On-site parking 

  • Endless free coffee and tea, and a free lunch  

  • Free on-site hair salon 

  • On-site lifestyle Assist 

  • Electric vehicle scheme  

 
Health: 

  • Private Medical insurance for all employees 

  • Employee Assistance Program for employee and dependents 

  • Digital GP and prescription service 

  • Fertility treatment support 

  • On-site gym and sports centre 

  • On-site wellbeing centre 

#LI-DYSON
 


Dyson is an equal opportunity employer. We know that great minds don’t think alike, and it takes all kinds of minds to make our technology so unique. We welcome applications from all backgrounds and employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other any other dimension of diversity.