Medical Affairs Operations Coordinator

1 month ago


Welwyn Garden City, Hertfordshire, United Kingdom Amber Therapuetics Full time

Amber Therapeutics is a pioneering biotechnology company developing innovative therapies for patients worldwide. We are seeking a highly skilled Medical Affairs Operations Coordinator to join our team in Welwyn Garden City.

About the Role

This full-time, 12-month fixed-term contract offers a competitive salary of £35,000 - £45,000 per annum, commensurate with experience. You will be responsible for coordinating activities related to deep brain stimulation external studies sponsored by academic collaborators.

Main Responsibilities:
  • Primary contact for external sponsors utilising Amber devices in their clinical trials.
  • Coordinate supply of Amber devices with the Amber Manufacturing Team and external sponsors/clinical trial sites.
  • Arrange shipment of clinical trial products.
  • Ensure device accountability is maintained from a manufacturer perspective for devices.
  • Arrange repair and replacement of damaged or defective device accessories.
  • Coordinate the completion of Investigator Brochures and other documentation.
  • Coordinate risk assessments and risk management updates to supporting documents for implantable medical devices and external accessories.
  • Aid in the preparation of Competent Authority and Ethics Board submissions.
  • Coordinate on-site Clinical Operations Support for clinical trials run by external sponsors.
  • Additional related duties may at times include taking calls on evenings/weekends for time-sensitive patient case reviews and customer needs.
  • Reporting of Complaints and Adverse Events occurring in external sponsored Clinical Trials.
Requirements

We require a Bachelor's degree in a scientific, medical engineering, or health-related field, excellent written and oral communication skills, and experience working as part of a multi-disciplinary team. Knowledge of Clinical Research and GCP (Good Clinical Practice) is also essential.

Benefits

You will enjoy a range of benefits, including private healthcare, income protection, life assurance, a company pension scheme, and 27 days' holiday (plus bank holidays).

Join Our Team

Amber Therapeutics is an equal opportunities employer, committed to creating an inclusive environment for all employees. If you are a motivated individual with a passion for delivering exceptional results, we encourage you to apply for this exciting opportunity.



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