QA Auditor - Clinical Trials
Job Description:
Review of CRF Design against Protocol and Sponsor Specifications (SSPs).
· Audit of database against the CRF to ensure compliance to Protocol, Regulatory requirements, In-house SOPs and SSPs.
· Conduct audit of Clinical Data Management, Biostat and Programming, Consumer Research, and Software Development activities and communicate audit observations to the respective department. Ensure resolution of the same.
· Maintain all QA related documentation for Project as well as System.
· Review of Pharmacokinetic Tables.
· Audit of Study Reports.
· Review of Protocol and its attachments.
· Review of Statistical Analysis Plan (SAP) and Audit of Tables, Figures and Listings (TLs).
· Maintain, Track and Distribute SOPs and forms
Key Skills :
Company Profile
is a leading provder of clinical --- services
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