- 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, 21CFR
- 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 International
Beschrijving
Sr. Clinical Quality Lead page is loaded
Sr. Clinical Quality Lead
Apply locations Eindhoven Amsterdam Best time type Full time posted on Posted 2 Days Ago job requisition idJob Title
Sr. Clinical Quality LeadJob Description
T he 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 .
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About Us
At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people's health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.
For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.
We're committed to building a diverse and inclusive workplace culture where people feel heard, valued and connected. Because we know the possibilities are unlimited when people feel empowered to grow and succeed together.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members , marital or domestic partner status, or any other category protected by federal, state and/or local laws.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact , option 5, for assistance.
Equal Employment and Opportunity Employer/Disabled/Veteran
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