Overview
Provide support for pre-clinical, clinical and usability testing activities within the clinical dept. The team member will provide support in document management, data management and analysis. The team member will also support other functions such as regulatory, quality and marketing. Supporting post-market clinical follow up activities.
Responsibilities
* Assist data management of clinical and pre-clinical data including the creation of data management plans
* Assist in execution of pre-clinical studies
* Assist data processing activities
* Assist in data recording during usability and pre-clinical studies
* Assist with engineering documentation for clinical regulatory submissions and pre-submissions
* Assist in initial bench/pilot testing and writing or review of technical reports
* Assist in planning pre-clinical and usability studies including equipment sourcing and preparation of data recording templates
* Liaising with the training officer and assisting in the training of industrial placement students
* Assist in the preparation and organisation of stakeholder and advisory meetings
* Creating and updating documentation in accordance with ISO 13485, GLP and ISO 14155
Qualifications
* Relevant on-going degree course with acceptable 1st year results
* Relevant A-levels or equivalent
* Specific Knowledge: Knowledge and understanding of cardiovascular anatomy and physiology
* Knowledge of medical devices, particularly cardiovascular
* Knowledge or experience of general electronics hardware would be useful
System/Computer Requirements
* Basic Microsoft Office, MS Project, Adobe Acrobat
* Ability to utilise publication search engines
Key Competencies
* Excellent communication skills (both written and verbal)
* Problem solving and analytical skills
* Technical writing skills
* Time management skills
* High standard of work and strong attention to detail
* Good teamwork skills and ability to work as part of a multi-disciplinary team
* Ability to work under pressure against tight deadlines
* Demonstrate initiative
Pay rate will not be below any applicable local minimum wage rates.
#J-18808-Ljbffr