Job Description

The Trial Master File Specialist will report to Quality Assurance, and Operational Compliance and is responsible for uploading and delivery of Trial Master File (TMF) documentation to the sponsor. The TMF Specialist will also work with Operations to support projects by performing InStream review and TMF audit activities, as needed. The TMF Specialist will be tasked with upload and QC workflow Vault responsibilities as well as intake of customer feedback regarding TMF deliverables. The TMF Specialist will work within SDC via SDC SOP and sponsor TMF plans to support TMF quality and delivery.

Primary Responsibilities

• Upload and QC workflow responsibilities to deliver SDC TMF documentation in Sponsor/Partner eTMF environments.
• Ensure adequate documentation is returned by Sponsor/Partner to document TMF delivery.
• Perform InStream review or assist in audit activities of TMF.
• Transfer of SDC TMF documentation via other media, as required.
• Based on automated notifications, update project teams and training documentation within the ZenQMS application. Upload training certificates to SDCs Vault.
• Work with Sponsor/Partner to triage and resolve documentation issues within TMF delivered documentation. Work with Operations and other QA personnel to ensure correction, and delivery of corrections.
• Assist in SDC Vault upload, QC Review or development to keep eTMF current to industry expectations.

• Possess strong computer skills in Word, Excel, Outlook, and Adobe Acrobat
• Experience working with TMF and eTMF technologies within Clinical Trials

• Working Knowledge of ALCOA and Good Documentation Practice, Good Clinical Practice per ICH E6 R2
• Working knowledge of the TMF Reference Model, clinical trial activities, and related terminology
• Some experience in clinical research within a CRO environment is preferred
• General Aptitude in the art and science of quality assurance procedures and methods
• Excellent verbal and written communication skills

• Bachelors degree in applied, life science or engineering
• 1 year experience working with Trial Master File Reference Model formerly (DIA)
• 1 year experience working with Veeva Vault (preferred) or other eTMF
• Prior clinical trial business experience is a plus

Statistics & Data Corporation (SDC)