Senior Clinical Trial Operations Specialist

5 days ago


Cumberland, Maryland, United States Allen Spolden Full time

The TMF Specialist role at Allen Spolden is an exciting opportunity for a skilled professional to oversee the management and quality of essential clinical trial documents, ensuring compliance with regulatory requirements.

About the Job

We are seeking a highly motivated and detail-oriented individual to manage Trial Master File (TMF) filing activities, ensuring audit and inspection readiness for clinical trials. The successful candidate will work closely with multi-functional study teams and vendors to maintain TMFs in a state of inspection readiness.

Key Responsibilities:

  • Maintain study-specific TMF Management Plan
  • Perform Quality Control (QC) on TMF documents to ensure high quality per data quality standards and specified system guidelines


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