Job Description

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

Primary Responsibilities

• Provide back-up upload assistance and perform 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 audit activities of TMF.
• Track and create lessons learned documentation regarding customer feedback on TMF delivery items.
• Transfer of SDC TMF documentation via other media as required.
• Work with Sponsor/Partner to triage and resolve documentation issues within TMF delivered documentation, to include a risk assessment of feedback. Work with Operations and other QA personnel to ensure correction, approval and delivery of corrections.
• Provide metrics of TMF delivery and sponsor/partner correction requests to QA management.
• Assist in SDC Vault upload, QC Review or development to keep eTMF current to industry expectations.
• Review Project level training within ZenQMS and monitor progress to meet SOP and regulatory requirements.

• Possess strong computer skills within 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
• Strong 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

• Bachelor\xe2\x80\x99s degree in applied, life science or engineering
• 2 years experience working with Trial Master File Reference Model (formerly DIA)
• 1 year experience working with Veeva Vault (preferred) or other eTMF platform
• 5 years experience in Quality Assurance (GxP), preferably in clinical trials
• Prior clinical trial business experience is a plus, prior CRO experience a plus

Statistics & Data Corporation (SDC)