Clinical Quality Assurance Specialist

11 hours ago

Kanpur, Uttar Pradesh, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000

Senior Compliance Officer Role

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

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The successful candidate ensures compliance with applicable regulations and guidelines, maintains inspection/audit readiness, and safeguards human subjects and data integrity.

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The ideal candidate has a strong eye for detail, excellent conflict management skills, and experience handling audits & inspections.

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Key Responsibilities:

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  • Develops and implements risk-based Quality Compliance within the function.">
  • Identifies and decides team member's job-specific SOP training requirements.">
  • Prepares SOPs related to QC function and supports review of SOPs specific to Medical science, Clinical team, and Data Management team.">
  • Reviews clinical trial medical science-related activities like Synopsis, Protocol, Clinical Study Report (CSR), and appendices.">
  • Reviews clinical trial operation-related activities, related tools, plans, and documentation.">

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