You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations
Job Summary
You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations.
The Senior Local Compliance Specialist will collaborate with the Compliance Managers, the Country Head, the Clinical Research Managers and the local teams in the Northern European cluster, carrying out the clinical trials, consisting of Local Trial Managers (LTM), Site Managers (SM) and Clinical Trial Assistants (CTA).
We are looking for a driven Senior Local Compliance Specialist to be located in Breda, the Netherlands.
Matching Summary
You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations.
Skills & Requirements
Must-have
GCP, local laws, and regulations
clinical research and/or quality assurance
pharmaceutical industry experience
compliance monitoring
risk management
local regulatory intelligence
Nice-to-have
analytical skills
quick learning
problem-solving abilities
strong communicator
team player
persistent
flexible
work independently
diplomate
Key Requirements
BA/BS degree in Life Sciences or related scientific field
minimum 4 years equivalent experience
minimum of 3 years of previous pharmaceutical industry experience
at least 2 years of GxP experience within clinical research and/or quality assurance
Experience in phase 1, 2, 3 clinical trials is a plus