Job Description

Job Overview
Serve as the liaison between Records Management and user departments regarding Trial Master files. Apply clinical research Records Management expertise to provide project related assistance across multiple project(s), sites, and project teams. Ensure all work is conducted in accordance with Standard Operating Procedures (SOPs), policies, practices, good clinical practices, applicable regulatory requirements, and meets quality and timeline metrics. May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources.

Essential Functions:

  • Quality Control (QC): Meticulously reviews essential clinical documents to ensure they meet ALCOA++ principles, ICH-GCP guidelines, and Good Documentation Practices (GDP).
  • Metadata & Indexing: Uploads, classifies, and verifies document metadata (e.g., document dates, types, version control) to ensure easy retrieval.
  • Completeness Tracking: Rev...

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