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Qa Auditor Cliantha Research

8.0 - 13.0 years

8 - 18 Lacs

ahmedabad

Work from Office

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,...

Posted 1 month ago

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