Description
Job Description:All aspects of clinical trial project management including:
* Development of clinical study protocols and supporting documentation
* Liaising with clinical trial sites
* Submission of clinical trial applications to regulatory authorities
* Coordination of clinical trial operations to ensure timely study completion
* Managing the activities of CRO or sub-contract monitors
* Writing clinical trial reports and clinical evaluation reports
* Assistance in the selection of CROs
* Maintaining compliance to relevant legislation and regulations in respect to clinical operations
* Management and continuous improvement of the clinical QA system, in collaboration with the QA manager
Desired Skills and Experience:
* At least 5 years of experience in clinical trials management in the medical devices sector, preferably with some IVD experience
* Track record of delivering clinical studies to time and budget
* Life sciences degree
* Knowledge of statistics
* Experience of submissions across the EU
* Strong experience of regulations governing clinical research
* Experience of post market studies and registries is desirable
* Excellent organisational, communication, and time-management skills
* A second language is beneficial, but not mandatory
* Aptitude for a fast-paced start-up environment, where a hands-on approach is vital
* The position will require some travel
This is an urgent requirement, and the ideal candidate will be able to start fairly quickly. This is an excellent opportunity to work for a fast moving organisation, offering competitive rates. If you are interested in this position and would like some more information please call Hailey McDermott on and send an updated CV.
Please also pass this opportunity onto anybody you know who may be interested in this as we do offer £200 referral vouchers.
I look forward to hearing from you,