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Senior Clinical Evidence Evaluation Manager

Location: Hull
Company: Smith & Nephew
Hours: Full time
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Role Title

Senior Clinical Evidence Evaluation Manager

Location

Hull, UK (UK based remote working will be considered)

Rewards

Competitive salary and an excellent benefit package on offer

Summary

At Smith+Nephew, we believe in our products. We believe that through innovation, development and supporting our customers and patients we can help others achieve a Life Unlimited! Long before any of this is possible, we have to go through many steps that will validate and verify our products, including evidence gathering and evaluation and design verification and validation.

To support our continued transition to EU MDR, our clinical evidence requires evaluation and the documentation maintained, compiled and submitted. This role requires experience! A knowledge steeped in clinical/scientific research to deliver changes to existing reports and the compilation of new reports. Couple that with the experience of managing, coaching and mentoring a team to deliver against business aims and strategy.

This team conducts literature searches, extracting all relevant data from supporting documents to compile Clinical Evaluation Reports (CER), along with other documents such as Clinical Evaluation Plans (CEP) and Summery of Safety and Clinical Performance (SSCP). Experience managing similar teams of clinical or scientific professionals is a huge advantage for us. That and an understanding of the regulatory framework, as the documents will be compiled in accordance to the relevant regulations. All this will ensure our products make it to market, so we can offer the care and support our customers need.

Sound exciting? We believe so.

Essential Job Functions

  • Strong and capable manager/leader of scientific/clinical evidence teams
  • Manage teams to deliver CERs, CEPs and SSCPs and other documents required for CE registrations
  • Working in partnership with other clinical evidence teams to get input from other functions and approval for evidence evaluation documentation
  • Manage and support other projects across wider teams through knowledge and information gained in the Clinical Evaluation process e.g. compiling validation summaries that require clinical evidence as part of the design history file

Requirements

  • Preferably educated to masters or PhD level in a biological or clinical setting.
  • Proven experience performing literature reviews, writing clinical and scientific documents, analysing data sets and communicating the findings is essential
  • Experience working within a medical device or pharmaceutical organisation in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.

Applications:

If you share our passion for pioneering innovation and can demonstrate how you meet the criteria outlined, we would love to hear from you.

We continue to actively build an environment where every individual can fulfil their potential and be proud ambassadors for Smith & Nephew, our customers and their patients.

We value the diversity of our people and welcome applications from everyone.

It's more than business at Smith+Nephew - it's personal. What we do every day, changes lives every day.

Healthcare is in Smith+Nephew's DNA. From a single pharmacy in Hull, UK to a presence in over 100 countries, we've spent more than a century and a half working at the leading edge of medical technology.

At Smith+Nephew, you will find a company of people who care about each other, about our customers and their patients, and about the communities where we live and work.

Join us as we continue to make our work personal, to innovate and to develop devices that help to restore patients' bodies, and enable them to regain their futures.

#LI-CL1

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