Qa Auditor Clinical Trials For A Cro Company At Ahmedabad
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
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Job Detail
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Job IdJD3095416
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationAhmedabad, Gujarat, India
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EducationNot mentioned
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ExperienceYear