Clinical Operations Coordinator/ Clinical Operations Associate
Location- Remote in United Kingdom, with some travel to HQ & sites
About the Company
We are working with a UK biotech organisation, who are developing a world first regenerative cell therapy to treat patients with hearing loss. There are currently no pharmaceutical therapies available, only medical devices, and this cell therapy has the potential to reverse the condition. This organisation has established a world-class team of audiology & clinical experts to address unmet clinical need & are focused on improving patients' quality of life on a global scale.
About the Role
This role is an exciting opportunity to join as Clinical Operations Coordinator/ Associate and sits within the Clinical Team who are currently delivering a FIH trial. The clinical operations team works alongside clinical development colleagues & in a very close partnership with trial sites, and this role will support the day-to-day running of clinical studies & trials, from site set-up to close-out. This is a unique opportunity to be part of a world-class cross-functional team delivering a first in class ATMP to the clinic for patients currently living with an unmet clinical need.
You will report into the Clinical Operations Manager.
We are looking for candidates who have the below experience:
* University degree within the life sciences
* Experience working in a clinical trial research environment, ideally from the sponsor side of clinical trial delivery
* Experience working on a clinical trial within NHS secondary care would be beneficial
* Experience maintaining a Trial Master File and/or Site File to an inspection ready state
* Prior experience directly supporting trial sites (training, central or remote monitoring, assistance with data queries)
* A willingness to work operationally and "hands-on" when required to get tasks completed
* A desire to work in a biotech environment which can be fast-paced & demanding, whilst also being able to adapt to any strategic changes in pipeline direction.
* A proactive team player with the ability to collaboratively work with colleagues from many areas of expertise and levels of seniority
Please apply with an up to date CV for consideration.