Clinical Quality Assurance Specialist

2 days ago


Lucknow, Uttar Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,20,00,000

Job Title: Clinical Quality Assurance Compliance

Overview:

This is a role that oversees clinical trial activities from a quality perspective. It ensures compliance with applicable regulations and guidelines to guarantee inspection and audit readiness at all times.

The successful candidate will be responsible for ensuring the integrity of clinical data, protection of human subjects, and internal consistency through Quality Compliance measures.

Key Responsibilities:

  • Establish procedures and training for teams to ensure protection of human subjects from research risks.
  • Develop and implement a risk-based approach to Quality Compliance within the function.
  • Identify and decide team member's job specific SOP training requirements in view of their role.
  • Preparation of SOPs related to QC function and support in review of SOPs specific to Medical science, Clinical team and Data Management team.
  • Quality review of clinical trial medical science related activities like Synopsis, Protocol, Clinical Study Report (CSR) and appendices.
  • Quality review of clinical trial operation related activities, related tools, plans and documentation.
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