Study Start-Up Manager - Medical Devices

Responsibilities:

  • Efficiently manage and successfully execute all aspects of global device trial start-up according to Sponsor specifications;
  • Oversee regional and/or global operational team preparing submission packages
  • Prepare and/or review documents for RA and EC submission packages
  • Review pertinent regulations to develop proactive solutions to start-up issues and challenges
  • Provide advice to sponsors and project teams on device regulations and strategies
  • Present during bid defenses, general capabilities meetings, and audits.

 

Qualifications:

  • Life sciences degree
  • More than 5 years of experience in devices clinical research.
  • Essential to have knowledge and experience with Device Clinical Trial Applications within Europe.
  • Advantage to have knowledge and experience with Pharmaceutical Clinical Trial Applications within Europe.
  • Strong oral and written communication skills.

 

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

 

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

 

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.

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