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Job #03485

About our client Our client is a young venture-backed medical device company headquartered in Southern California that is focused on the development and commercialization of innovative drug delivery and surgical wound care products. The company has an experienced management team, strong financing and a robust pipeline of products in development with excellent momentum. This is a unique opportunity for someone that wants to put their drive and initiative to work! Position Location Clinical Affairs Manager Irvine, CA - South Salary Highly competitive package, commensurate with experience Responsibilities 1) Preparation of clinical trial protocols; Preparation of Case Report forms and study site documents. 2) Selection and Qualification of Investigators and Investigational sites. 3) Site contract preparations and negotiations. 4) IRB and Ethics committee submissions; Clinical Site Training. 5) Clinical Trial Monitoring; Clinical Data Analysis and Clinical Report Writing. Requirements 1) Bachelor's degree in a scientific or health-related field is required (minimum). 2) 5-7 years experience in clinical research within the medical device sector. 3) Must have prior experience in managing medical device clinical trials. 4) Experience in running both domestic and international trials highly preferred. 5) Successful previous experience as a Clinical Research Associate (CRA) desired. 6) Must be self-motivated, hands-on, and able to work effectively with minimum supervision.