Manage paper documents (inc. filing and/or shipping), if required
Process, upload, and index TMF documents
Track and maintain TMF documentation
Perform in-line document QC
Support TMF set-up based on pre-defined structure and confirmed study requirements
Amend the study-specific TMF structure in line with confirmed study events and changes
Support creation of the study-specific TMF Index, or equivalent
Run metrics reports, communicating output
Identify and share high-level trends in metrics reports
Perform TMF quality review (QR)
Communicate QR findings and identify high-level trends
Conduct risk-based TMF Analysis (e.g., Heatmaps), if required
Support remediation projects, including query management and remediation tasks
Support retrospective TMF reconciliation projects, performing assigned tasks
Understand and utilise appropriate escalation pathways
Communicate with the study team on TMF-related matters

Degree level education preferred, but equivalent work experience in a relevant field considered
2 years’ relevant industry experience in Clinical or TMF Operations oversight
Excellent knowledge of document recognition and Good Documentation Practices (GDP)
Working knowledge of eTMF system
Familiar with:
Clinical Trial Lifecycle
TMF Reference Model (or equivalent)
Referencing/Applying applicable resources
TMF Health & Metrics
TMF Quality Review Process
Internal communication/escalation pathways
Aware of:
TMF Lifecycle
Other clinical/document management systems
TMF Stakeholders
TMF Set-up process
TMF Management Plans
TMF Training
Inspection Readiness
External communication/escalation pathways
Independent in:
Verbal and written communication
Interpersonal interactions
Organization
External collaboration
Negotiation/conflict resolution
Working under pressure
Information analysis

Benefit offerings outside the US may vary by country and will be aligned to local market practice.

TMF Study Administrator

Key skills