Clinical Quality Assurance Specialist

20 hours ago


Alleppey, Kerala, India beBeeCompliance Full time ₹ 1,81,31,845 - ₹ 2,03,17,794
Job Title: Quality Assurance and Compliance Officer

A highly skilled Quality Assurance and Compliance Officer is required to oversee end-to-end clinical trial activities from a quality perspective. This role will be responsible for ensuring adherence to applicable regulations and guidelines, as well as establishing procedures and trainings to safeguard human subjects and data.

Key Responsibilities:
  • Review of all study-related activities, processes, and procedures
  • Development and implementation of a risk-based approach to quality compliance
  • Quality review of clinical trial medical science and operation-related activities
  • Maintenance of oversight on team member training requirements
Required Skills and Qualifications:
  • 5 years' experience in a CRO/Pharma/Biotech organization with experience of quality activities in the clinical research department
  • Strong eye for detail and ability to spot inconsistencies
  • Good conflict management skills
  • Experience in handling audits and inspections
  • Thorough knowledge of recent GCP guidelines and other applicable regulations pertaining to clinical trials


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