Clinical Trials Quality Assurance Specialist

hace 4 días


Buenos Aires, Buenos Aires C.F., Argentina PSI A tiempo completo

Job Overview

PSI is seeking a highly skilled Clinical Trials Quality Assurance Specialist to join their team. This role will involve ensuring high-quality standards within clinical trials and internal company processes.

Key Responsibilities

  • Planning, conducting, and reporting of QA audits
  • Communicating with project teams regarding QA study audits
  • Assembling QA audit documentation
  • Training PSI Operations staff in quality management topics

About the Role

The ideal candidate will have a minimum of 3 years' experience in quality management or quality assurance in a clinical study environment. They should also have excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations.

Requirements

  • M.D., PharmD, or degree in life sciences preferred
  • Full working proficiency in English required
  • Proficiency in MS Office applications necessary
  • Able to travel for site audits

Benefits and Compensation

The estimated salary for this role is $80,000-$100,000 per year, depending on location and experience. In addition to a competitive salary, PSI offers a range of benefits, including professional development opportunities and a supportive work environment.



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