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Qa Auditor

3 weeks ago


Ahmedabad, Gujarat, India Cliantha Research Full time

Role & responsibilities

  • Conduct external site audit (Late Phase) to ensure compliance with SOPs, Protocol, ICH GCP, and applicable regulatory requirements.
  • Review of study documents like study protocol, inform consent, eCRF, Data management plan, study plans, Statistical analysis plan (SAP), clinical study report, etc.
  • Audit study database in various clinical data management systems.
  • Review and maintain QMS documents like change control, protocol deviation, etc.
  • Review study TLFs (Table, listing and figure)
  • Review validation documents of software used in clinical studies like clinical data management system (CDMS), eTMF, Clinical trial management system (CTMS), etc.
  • Responsible for planning, conducting and reporting of system audit of clinical trial, clinical data management, software development and Bio-stat departments.
  • Responsible for planning, conducting, and reporting of vendor audits.
  • Review SOPs of various departments like clinical trial, clinical data management, software development, Bio-stat, etc.

Preferred candidate profile

  • Minimum 8 years of experience
  • Candidate must have experience in the Clinical Trials field
  • QA or CT Operations experience preferred