Clinical Affairs Specialist
- Galway, Republic of Ireland
- Regulatory Affairs (RA)
I am working closely with an innovative medical device start-up in Galway who are one of Europe's leading developers in the field of neurovascular medical devices. There's never been a better time to join the team, with manufacturing ramping up due to growth. Located in the heart of Galway's medtech hub, the company have moved to a new facility to accommodate the increase in headcount and product development. They truly care about their patients and are looking for a dedicated Clinical Affairs Specialist to join them.
As Clinical Affairs Specialist, you will ensure the most effective and efficient conduct of clinical research studies by supporting clinical operations activities and provide clinical expertise. You will also support external CRO relations and activities.
Some of your day-to-day will include:
- Help with the set-up, organise and maintain clinical study documentation
- Assume the internal lead in trial progress tracking
- Track the budget spend and highlight deviations
- Co-ordinate ordering/dispatch and tracking of trial materials
- Contact clinical sites for specific requests
- Assist in the tracking and distribution of safety reports.
- Assist with Investigator Meeting coordination, activities preparation and generate meeting minutes.
You have a Life Science/Nursing degree with 4 years+ post-grad experience in a similar role. You have strong knowledge and experience of clinical research operations (including interpretation and implementation of FDA and EU regulations, ICH GCP guidelines). You also have experience in managing outside-vendors. Previous experience in the Neurovascular field is a plus!
Permanent contract, pension contribution, annual bonus, healthcare, 25 days' holidays, competitive salary depending on experience.
To find out more about Real please visit www.realstaffing.com
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