Clinical Assurance Specialist

2 weeks ago


Morādābād, Uttar Pradesh, India beBeeQuality Full time ₹ 20,00,000 - ₹ 25,00,000
Clinical Assurance Specialist

Job Overview:

We are seeking a seasoned Clinical Quality Assurance Compliance expert to oversee clinical trial activities from a quality perspective. This role will be accountable for ensuring compliance with regulatory requirements, industry standards, and best practices.

Main Responsibilities:
  • Develop and implement risk-based quality compliance strategies within the function
  • Identify and determine team member's job-specific SOP training needs
  • Prepare and review SOPs related to QC functions
  • Conduct quality reviews of clinical trial medical science and operations-related activities
  • Maintain oversight of training to ensure all team members are trained on each SOP as required
Requirements:
  • 5 years' experience in a CRO/Pharma/Biotech organization in a Quality department with experience of Quality activities in Clinical Research departments
  • Strong attention to detail and ability to identify inconsistencies
  • Good conflict management skills
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations, and other applicable regulations pertaining to clinical trials


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