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QA Auditor

4 weeks ago

Ahmedabad, India Kaapro Management Solutions Full time

Opening: 1 Nos.- Job ID: 62623- Employment Type: Full Time- Reference:
- Work Experience: 2.0 Year(s) To 6.0 Year(s)- CTC Salary: 5.00 LPA TO 6.00 LPA- Location:

- Ahmedabad

Posted On: 21st Jun, 2023
**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**:

- Clinical Trial
- Data Management

**Company Profile**:
is a leading provder of clinical - services

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