Clinical Studies Report Reviewer

at  SQA Services

SQA Services is a leading Quality Assurance and Supply Chain consultancy firm. SQA manages Supplier Audit and Supplier Development programs for customers in many industries including Pharmaceutical, Medical Device, Automotive, Aerospace, and Electronics manufacturing. Clients leverage SQA’s network of Quality Professionals in more than 50 countries as an extension of their own Supplier Quality teams.
Job Title: Clinical Studies Report Reviewer
Contract Duration: 6 months
Type: Full time hours, first shift on EST
Job Responsibilities:

Ensure the clinical reports re adherent to the client’s procedures, including but not limited to:

• Study Details
• Demographics
• Test Product Accuracy
• Study Plan
• Results
• Source verify data with source documents from CRO and master study file, protocol, and product information
• Any reporting on Adverse Events
• Deviations are clearly described, and rationale has been provided for their approval
• Results are substantiated by scientific data and rationale
• Collaborate on continuous improvement activities for the client’s Clinical Quality Program, as it relates to the content of the clinical study reports.

Please refer the Job description for details