Senior Clinical Quality Assurance Professional

20 hours ago


Ajmer, Rajasthan, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 20,00,000
Senior Manager Clinical Quality Assurance Compliance

This is a senior-level role within our organization responsible for ensuring the highest standards of quality assurance in clinical trial activities.

  • Key Responsibilities:
  • Develop and implement a risk-based approach to quality compliance, safeguarding trial participants and data in line with regulatory requirements and best practices.
  • Establish procedures and trainings to ensure protection of human subjects from research risk, reliability/integrity of data, and internal consistency.
  • Identify team member job-specific SOP training requirements and maintain oversight of training to ensure all team members are trained as required.

Requirements:

  • 5 years' experience in a CRO/Pharma/Biotech organization in quality department with experience of quality activities in clinical research department.
  • Strong analytical skills, ability to spot inconsistencies, and good conflict management skills.
  • Experience in handling audits & inspections, thorough knowledge of recent GCP guidelines, ICMR guidelines, and other applicable regulations pertaining to clinical trials.


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