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Process Improvement Manager: Clinical Quality
2 weeks ago
Role Overview:
We are seeking a Regulatory Compliance Specialist to join our team. As a GCP Advisor Specialist, you will be responsible for managing updates to our standard operating procedures (SOPs) covering the Establish Clinical Evidence process, ensuring compliance with GCP and regulatory requirements.
Your Key Responsibilities:
- Manage updates to SOPs covering the Establish Clinical Evidence process
- Ensure compliance with GCP and regulatory requirements
- Support digitalisation of key processes and procedures
- Ensure global consistency and compliance in clinical development processes
Requirements:
- A degree in nursing, pharmacy, medicine, science or similar
- A strong command of written and spoken English
- At least 8 years of experience in clinical research and drug development, as well as a strong knowledge of GCP and other relevant regulations
- Experience with digitalization of processes to minimize risks through design and focus on quality that matters is preferred
- Experience within clinical quality assurance, trial management/monitoring, or GCP Audits is required
What We Offer:
We offer a dynamic and challenging role within clinical process management, where you will have the opportunity to work independently, leveraging your strong GCP knowledge and staying updated with changing regulations.