Clinical Research Specialist - Loughborough
6 months initially with a view to being extended
Have you got experience of leading clinical research programs/studies?
My Client is seeking a Clinical Research Specialist to support new product development projects in Skin & Wound Care and Infection Prevention Divisions .
Overall responsibilities of this role:
*To provide clinical evidence to support new product programs.
*This role will provide valid clinical evidence and champion clinical research requirements in new product programs.
*This function will design and implement research studies and other evidence programs supporting claims validation and overall CE marking of new medical devices.
*As a team member in NPI projects, will coordinate safety testing of new products and prototypes to, where applicable meet requirements of ISO10993.
*This role reports to the Technical Manager and will work closely with NPI teams (as member) and clinical research colleagues in Germany and US.
* Independently leads clinical research programs for new product development projects and commercialised S&WC and I.P. products in UK.
* Participates on product teams to develop and carry out clinical safety and efficacy plans for new products and product modifications, and clinical plans for marketed products
* Responsibility for coordinating safety plans with Corporate Tox, and scheduling of biocompatibility testing.
* Responsibility for ensuring product claims are identified and documented according to NPI process
* Responsible for timely development of evidence to validate product claims
* Makes research agreements and agrees study costs in line with clinical research budget
* Supports Product Development Lab with product prototype testing during development.
* Provides support for Risk Review process.
* Supports Regulatory Affairs in completion of necessary regulatory documents as required.
* Ensure studies are GLP and GCP compliant where applicable
· Bachelors Degree
· Clinical research experience in medical devices or pharmaceuticals
· Experience leading and/or participating in cross functional teams
· Experience in the Medical Device and/or Pharmaceutical Industries
· Master's and/or PhD in Health Sciences, Epidemiology, Pharmacy or related science field
· A Medical Doctor (MD) with a clinical research background
· A Registered Nurse (RN) with a clinical research background
If you have experience of leading clinical research studies, preferably to EU regulations, and would like to join a leading global company as a Clinical Research Specialist then please apply now.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency. SRG, winners of the Recruitment Professional Awards 2011 'Best Company to work for' and 'Best People Development Business' awards, and the only "highly commended" company in the Annual Recruiter Awards for Excellence 2011, for 'Best Small Recruitment Agency to Work For'.
Deadline: Thursday, 15 August 2013