Melody Fang
About Melody Fang
Melody Fang is a Clinical Trial Manager with extensive experience in clinical trial management, focusing on compliance with ICH guidelines, GCP, and CFR. She has worked in various roles within the medical device industry, specializing in therapeutic areas such as Neurovascular and Cardiovascular.
Current Role at Cardiac Dimensions
Melody Fang has been serving as a Clinical Trial Manager at Cardiac Dimensions since 2021. In this role, she focuses on overseeing clinical trials, ensuring compliance with regulatory standards, and managing various aspects of trial execution. Her responsibilities include coordinating with cross-functional teams to facilitate the progress of clinical studies, particularly in the cardiovascular field.
Previous Experience at Masimo
Prior to her current position, Melody worked at Masimo as a Clinical Research Associate II from 2016 to 2018. Based in Irvine, California, she contributed to clinical research activities, focusing on compliance with industry standards and regulations. Her experience at Masimo provided her with a solid foundation in clinical trial management and regulatory compliance.
Education and Expertise
Melody Fang holds a Bachelor of Science degree in Biological and Biomedical Sciences from the University of California, Irvine, where she studied from 2010 to 2014. She furthered her education by obtaining a Master of Science in Clinical Research Management and Regulatory Science from Arizona State University, completing her studies from 2017 to 2019. Her academic background supports her expertise in managing clinical trials, particularly in the medical device sector.
Clinical Trial Management Skills
Melody specializes in conducting Class II and III early feasibility and pivotal IDE clinical trials on both national and global scales. She has extensive experience in preparing for and managing audits, including BIMO and DEKRA audits, as well as internal and FDA audit preparations. Her strong focus on compliance with ICH guidelines, GCP, and CFR enhances her effectiveness in clinical trial management.
Current Role at Medtronic
In addition to her role at Cardiac Dimensions, Melody Fang has been working at Medtronic as a Senior Clinical Research Specialist since 2020. In this position, she applies her knowledge and skills in clinical research to support the development and management of clinical trials, particularly in therapeutic areas such as Neurovascular, Cardiovascular, Interventional Cardiology, Fluid Therapy, and Respiratory Monitoring.