Clinical Assurance Specialist

2 weeks ago


Guntur, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Job Summary

We are seeking a skilled Clinical Quality Assurance and Compliance Specialist to join our team.

Key Responsibilities:

  • Develop risk-based quality compliance strategies to safeguard trial participants and data in compliance with regulatory requirements and best practices.
  • Establish SOPs for the QC function, including medical science, clinical teams, and data management.
  • Review and approve SOPs, provide input on protocol development, and review clinical study reports.
  • Ensure 24x7 inspection/audit readiness through regular quality reviews of clinical trial activities.

Requirements:

  • Strong attention to detail with excellent conflict management skills and ability to spot inconsistencies.
  • Proven experience handling audits and inspections, particularly with FDA and DCGI.
  • Thorough knowledge of GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations.
  • Ability to work effectively in a matrix business environment with strong track record of success.


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