MM Staffing & Career Consultants Pvt Ltd
Location
Ahmedabad | India
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
Clinical trial,Data Management
Designation: QA Auditor - Clinical Trials
Vacancies: 1
Experience: 2.0 Year(s) - 6.0 Year(s)
Job tags
Salary
Rs 5 - 6 lakhs p.a.
