Clinical Trial Assurance Specialist

1 day ago


Rajahmundry, Andhra Pradesh, India beBeeCompliance Full time ₹ 1,00,00,000 - ₹ 1,50,00,000
Job Title: Senior Manager Clinical Quality Assurance Compliance and Training

This role involves overseeing end-to-end clinical trial activities from a quality perspective.

  • Oversight Role:
  • Oversight of study-related activities, processes, procedures, and adherence to applicable regulations and guidelines.
  • Audit/Inspection readiness at all times.
Main Responsibilities:
  • Quality Compliance Strategy:
  • Developing and implementing risk-based approaches to Quality Compliance (QC) within the function to safeguard trial participants and data.
  • Maintaining oversight of training to ensure team members are trained on each SOP as required.
Required Skills and Qualifications:
  • 5 years' experience in a CRO/Pharma/Biotech organization in a Quality department with Quality activities experience in Clinical Research departments.
  • Strong eye for detail and ability to spot inconsistencies, good conflict management skills.
  • Experience handling audits & inspections of regulatory bodies.
  • Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations.


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