Responsible for ensuring the quality of clinical regulatory documents by conducting quality control (QC) review utilizing checklists for all applicable documents, providing QC review documentation to Document Management for the Trial Master File (TMF), and, ensuring QC review documentation from all applicable functional areas is completed and provided to Document Management for the TMF per the established business processes and procedures.
-Must be familiar with ICH and GCP Guidelines.
-Must demonstrate good interpersonal and organizational communication skills.
-Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
-Conducts independent quality review of documents by checking against source (documents and/or data) to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs (TLGs).
-Deliver documented quality review comments/checklist to document author through resolution.
-Ensures QC review documentation from all applicable functional areas is completed and provided to Document Management for the TMF per the established business processes and procedures.
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