Senior Executive - Clinical Quality Assurance

5 - 8 years

5 - 12 Lacs

Posted:3 weeks ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  • Responsible for developing, establishing, and maintaining QA procedures related to clinical trials to ensure compliance with applicable regulatory guidelines.
  • Review of clinical trial-related documents such as Investigators Brochure, Clinical Trial Protocol, Informed Consent Document, and associated plans and manuals.
  • Ensuring the conduct of clinical trials as per applicable guidelines, SOPs and protocols.
  • Responsible for planning, conducting and reporting of audits pertaining to study.
  • Conduct of facility audits for its compliance and for ensuring CAPA implementation.
  • Conduct of site audits and TMF audits as per study protocol, to generate reports and ensure CAPA implementation for the same .
  • Responsible for managing external audits/inspections and overseeing CAPA resolution and implementation.

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