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Clinical Strategy Specialist

PE Global
Job LocationHull
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeContract , full-time

Job Description

PE Global is currently recruiting for a Clinical Strategy Specialist for a leading multi-national medical device client based in Hull.This is an 11 month contract and the successful candidate will work to deliver the required evidence and support the ongoing transition to MDR for our clients Advanced Wound Management franchise and to provide continuing support for our clients productsto access global markets, and offer the required support to their customers. The successful candidate will be required to take ownership for the Investigator Initiated Studies (IIS) program, and support ongoing submissions for volunteer and clinical studyproposals; while ensuring all Post Market Clinical Follow-up (PMCF) plans are detailed and meet the changing requirements of MDR.Role:

  • Deliver PMCF plans and documentation according to commitment trackers and remediation plans for MDD and MDR, review and approve with Clinical Strategy leads in a timely manner.
  • Working closely with Post Market Surveillance (PMS), Evidence Evaluation and Global Clinical Study (GCS) teams and to lead a cross functional approach to planning and communicating any needs for MDR.
  • Manage the IIS process requests, working with clinical investigators delivering studies from request to completion. Working with GCS and commercial teams to ensure the ISS process meets the companys strategic priorities.
  • Support Clinical Strategy and Operations teams with study design, planning and execution. Ensure the needs of clinical studies are understood, and help direct business activity towards positive and required outcomes, including activities required for asmooth MDR transition.
  • Develop volunteer study proposals with GCS leads, for approval. Delivering this will require close links and close working with NPD, Product Support and Volunteer Study teams.
  • Submit evidence generation projects for review and approval. Support the transition to Clinical Study teams for further design and development.
  • To help achieve compliance in cGMP, cGDP, ISO 9001, ISO 13485, US FDA 21 CFR Part 820
Requirements:
  • Degree level education in a biomedical or clinical field
  • Knowledge of wound care practices would be beneficial
  • Experience in critically appraising clinical evidence and analysing relevant datasets
  • Some experience working within the Medical Device or Pharmaceutical industries, Or a PhD in a biomedical or relevant field
Interested candidates should submit an updated CV.Please click the link below to apply, call Jennifer Horgan on + or alternatively send an up to date CV to***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, weare making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you justwant to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in thisadvert.

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