Clinical Affairs ScientistOverview
My client is an industry leading and global organisation within the medical diagnostic sector. They are recruiting an exciting role within the Clinical Affairs Team with the responsibility of the design, performance and interpretation of clinical studies to support the company's Product Development ambitions.
* With support of the wider clinical affairs team you will ensure clinical study protocols and associated forms are prepared and uploaded
* You will have the responsibility of ensuring that the clinical study sites are appropriately equipped to carry out studies (including movement and calibration of equipment and organisation of study material) alongside taking ownership of data verification, analysis and reporting.
* Ensuring that studies are carried out in accordance with the Company's Quality Management System and to the required Regulatory standards.
* You will support with regards to the clinical protocol development process including clinical protocol development, amendments and related documents.
* You will ensure all clinical study forms are accurately completed and the data has been entered appropriately.
* You will contribute to the scientific input given for the development of trial-related documents and then obtain approval from internal stakeholders
* You will collaborate with the Clinical leadership and investigators to ensure their feedback is adequately integrated into protocol
* Create and maintain clinical project files to internal standards and regulatory requirements and meeting FDA/GCP/ICH guidelines
Essential Technical skills and abilities* Minimum BSc Degree or Equivalent in Life Sciences or Clinical Management degree
* 12 months experience in clinical trial design, set-up and execution or relevant
* Experience in clinical trial data management essential
* Competent in the use of Windows and Office based applications; Word, Excel, PowerPoint.
* Ability to organise and prioritise workloads and work under pressure.
If you or anybody in your network is interested in this role then please get in contact with Marcus on 0121 726 9711
See more at: www.srgtalent.com/jobs
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