- Provide leadership in execution of clinical studies to deliver high quality data to support Philips on time, within budget and in compliance with all applicable regulations and Philips procedures.
- Drive adoption of compliant clinical study execution practices throughout Philips active clinical studies, including research and testing of products involving human beings.
- Develop and maintain the policies and procedures for the Clinical Operations function of Clinical and Medical Affairs.
- Support the clinical teams while acting as a Subject Matter Expert on clinical regulations, standards, and laws.
- Support, update, and maintain the Clinical Trial Management System application for clinical study execution and reporting.
- Develop and deliver clinical research focused trainings to many different audiences.
- Support CAPA and Root Cause Analysis work on Clinical CAPAs in a timely and effective manner.
- This role may require travel up to 10%.
- You've acquired a minimum of 7+ years' experience working in regulated (EU and US) Medical Device Clinical Study environments, with a focus on Clinical study execution, policies, and procedures.
- You have expert knowledge of applicable regulations/standards training (i.e. ICH, ISO 14155, ISO 13485, 21CFR820, 21CFR812...)
- You have expert CAPA Knowledge and experience.
- You have detailed knowledge of compliant Clinical Operations policies and procedures.
- You have excellent presentation skills and the ability to effectively communicate clinical trial outcomes to disparate audiences.
- You have a minimum of a Bachelor's Degree in Clinical/Health Sciences or related disciplines (Required), Masters or advanced degree desired.
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Sr. Clinical Quality Lead - Eindhoven, Nederland - Philips
Beschrijving
Job Title
Sr. Clinical Quality LeadJob Description
The Senior Clinical Quality Leader will play a critical role in ensuring Philips' execution of clinical studies is conducted according to Philips requirements, applicable regulations, and guidance.
Your role:
You're the right fit if:
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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