Masimo

Manager, Clinical Research Compliance

Masimo

52 Discovery, Irvine, CA 92618, USA
Full-TimeDepends on ExperienceSenior LevelBachelors
Job Description

Provide training and oversight to staff maintaining clinical trial master files to ensure their compliance with relevant regulatory and GCP quality standards and consistency with Masimo SOPs. Oversee and/or perform site monitoring (qualification, initiation, routine monitoring and close out visits).Manage monitoring schedule and monitoring resources to ensure studies are monitored in accordance to SOPs and monitoring plans. Provide input and support to maintain appropriate documentation of adverse events, device deficiencies, and protocol deviations, and collaborating in submission of MedWatch reports to FDA for events arising from clinical research activities. Identify potential risks and resolve issues relating to clinical research compliance. Develop and implement process improvement initiatives to strengthen Masimo clinical research study conduct and compliance. Interface with KOLs and Investigators.

Where is this job?
This job is located at 52 Discovery, Irvine, CA 92618, USA
Job Qualifications
  • Strong clinical background preferred. (e.g., respiratory therapy, nursing, pharmacology, physiology).

  • Clinical Research Associate certification.

  • Proven track record and experience in Clinical Research.

  • Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies.

  • Experience with medical devices preferred.

Required Skills
  • MS Word

  • Report writing skills

  • MS Excel skills

  • Analytical & strategic thinking

  • Time management competent

  • Data analysis and extraction

  • Graphing and plotting results

Soft Skills
  • Results Oriented

  • Verbal communication

  • written communication

  • Self-Motivated

  • Problem Solving Skills

  • Flexibility/Adaptability

  • Detail Oriented and Organized

  • Multi tasker

Compensation

According to JobzMall, the average salary range for a Manager, Clinical Research Compliance in 52 Discovery, Irvine, CA 92618, USA is $90,000 - $120,000 USD per year.

Additional Information
Masimo is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedSeptember 8th, 2022
Apply BeforeJune 21st, 2025
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About Masimo

Masimo is an American Irvine, California-based manufacturer of noninvasive patient monitoring technologies. The company sells more pulse oximetry to hospitals than any other company.

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