Clinical Quality Lead
Philips
- Cambridge, MA
- $162,000 per year
- Permanent
- Full-time
- Provide professional support 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.
- Aid in the adoption of compliant clinical study execution practices throughout Philips active clinical studies, including research and testing of products involving human beings.
- Collaborate with creation of 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 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 Hybrid role may require travel up to 10%.
- You’ve acquired a minimum of 4+ years’ experience working in FDA regulated 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 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),
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
- Project Management skills
- Ability to travel up to 30%
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