
Manager, Clinical Research Compliance
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.
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.
MS Word
Report writing skills
MS Excel skills
Analytical & strategic thinking
Time management competent
Data analysis and extraction
Graphing and plotting results
Results Oriented
Verbal communication
written communication
Self-Motivated
Problem Solving Skills
Flexibility/Adaptability
Detail Oriented and Organized
Multi tasker
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.
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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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