Clinical Quality Lead

Philips

  • Cambridge, MA
  • $162,000 per year
  • Permanent
  • Full-time
  • 16 days ago
Job Title Clinical Quality LeadJob DescriptionLooking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.In this role you have the opportunity toThe 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:
  • 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're the right fit if:US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
  • 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
. * US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
  • Project Management skills
  • Ability to travel up to 30%
About PhilipsWe 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 improve the lives of others.
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.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 .Philips Transparency DetailsThe pay range for this position is $94,000,000 to $162,000, Annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found .At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.Additional InformationUS work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.#LI-PHI#LI-HYBRIDThis requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

Philips