Senior Clinical Regulatory Compliance Specialist

21 hours ago


Thiruvananthapuram, Kerala, India beBeeCompliance Full time ₹ 2,00,00,000 - ₹ 2,50,00,000

Job Overview: Senior Clinical Quality Assurance Manager

The role involves overseeing end-to-end clinical trial activities from a quality perspective, ensuring adherence to regulatory requirements and guidelines.

This position is responsible for developing and implementing a risk-based approach to quality compliance, safeguarding participants and data integrity.

Key Responsibilities:

  • Establish SOPs for the QC function and review related SOPs for medical science, clinical teams, and data management
  • Quality assess clinical trial medical science activities, including synopsis, protocol, CSR, and appendices
  • Review clinical trial operations, tools, plans, and documentation for quality assurance

Essential Skills Include:

  • Minimum 5+ years' experience in CRO/Pharma/Biotech organizations
  • Strong attention to detail and conflict resolution skills
  • Familiarity with GCP guidelines, ICMR regulations, and applicable laws

A successful track record, demonstrated through performance ratings and professional achievements, is highly desirable.

We offer a dynamic work environment that fosters growth and development. Our team is committed to excellence and innovation, driving success through collaboration and mutual respect.



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