Clinical Quality Assurance Compliance Specialist

1 day ago


Udaipur, Rajasthan, India beBeeCompliance Full time ₹ 18,75,000 - ₹ 25,15,000

Job Title: Clinical Quality Assurance Compliance Specialist

Overview:

We are seeking a skilled Clinical Quality Assurance Compliance Specialist to oversee end-to-end clinical trial activities from a quality perspective.

Responsibilities:

  • Oversight of quality compliance (QC) activities across various teams, including Medical Science, Operations, and Data Management.
  • Review of all study-related activities, processes, procedures, and adherence to applicable regulations and guidelines to ensure inspection/audit readiness.
  • Establishment of procedures and training for teams to protect human subjects from research risk, ensure data reliability/integrity, and maintain internal consistency and QC measures.
  • Development and implementation of a risk-based and flexible approach to QC within the function.

Requirements:

  • 5+ years of experience in a CRO/Pharma/Biotech organization with expertise in Quality activities in Clinical Research departments.
  • Strong attention to detail and conflict management skills.
  • Familiarity with recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations.
  • Experience working in matrix business environments preferred.

Preferred Skills:
.

Additional Information:

This role requires a strong understanding of regulatory requirements and industry best practices. The ideal candidate will have excellent communication and interpersonal skills, as well as the ability to work effectively in a team environment.



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