Clinical Affairs Manager

Salary/Rate:90,000 - 110,000
Job type:Perm
Country:United States
Business Sectors:Regulatory Affairs, Clinical
Job ref:24450
Post Date:13. 09. 2023

About the Role

Clinical Affairs Manager
Chicago, Illinois

If you are interested in working with rapidly growing digital health start-up, supporting patient monitoring and diagnostics – we might have something for you!
Our client is looking for a Clinical Affairs Manager to join their team to develop and maintain the clinical strategy, all in accordance with current regulations.

About the role:
  • Development and management of clinical program, ensuring its compliance with EU MDR & FDA regulations.
  • Supporting business with the strategic input to clinical trial/study design and protocol development.
  • Leading & representing Clinical Affairs team, processes, programs across Sibel and external venues in partnership with senior management.
  • Management of 1 x CRA and supporting the Senior Management with the recruitment of the 2nd CRA.
  • Ensuring data excellence and timely completion of studies.
  • Provide guidance on all clinical operation logistics associated with execution of clinical studies (including clinical supplies, sample shipments etc.).
About you:
  • Bachelor’s or higher degree in Life sciences field is a must.
  • Several years of experience managing clinical studies/trials.
  • Experience in managing projects and working with clinical professionals.
  • Knowledge of ICHGCP, ISO 14155 & IRB guidelines.
  • Excellent written and verbal communication skills.
  • Great motivational and organisational skills.

If you are interested in finding out more about this or other vacancies within Med-Tech, please contact Kasia Krasuska on:

+49 30 16 63 83 76