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Clinical Affairs Manager

Company Name: Applied BioCode Inc.
Location: Santa Fe Springs, CA
Job Type: Full-Time
Contact Name: Briana Guedea
Phone: 562-273-0201
Fax:
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Salary:

Job Description

The Manager, Clinical Affairs is responsible for clinical research programs, including the direction, planning, execution, and interpretation of clinical trials in compliance with GCPs, SOPs and established timelines. Such clinical research programs include studies to support: 1) new product development 2) clinical trials for IVD products and 3) product improvements or additional claims. The Manager, Clinical Affairs is involved in the scientific conduct of clinical trials and acts as the leader of operational disciplines to guarantee release of high quality data, in close collaboration with the VP, Product Development.

Job Requirements 

  • Candidate must have minimum of 5 years clinical affairs experience with at least 3 years of experience in IVD industry, and prior experience with Class II/III IVD devices. Prior infectious disease or molecular diagnostic IVD experience a plus.
  • Strong knowledge and competence in application of CFRs, GCPs and ICH Guidelines required. Candidate must demonstrate proficiency in required software and computer skills. Candidate must demonstrate excellent written and verbal communication/ presentation skills to meet the needs of various audiences. Strong team leadership experience and motivational skills are essential.
  • Minimum of 3 years prior managerial experience
  • Clinical Affairs: 5 years
  • IVD : 3 years

 

Get full job description and requirements here