Qa Auditor Clinical Trials

Year    Ahmedabad, Gujarat, India

Job Description








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


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Job Detail

  • Job Id
    JD3207473
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Ahmedabad, Gujarat, India
  • Education
    Not mentioned
  • Experience
    Year