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Position Overview Planet Pharma's biotech client is seeking an experienced CTA/eTMF Specialist to support the accelerated review and remediation of electronic Trial Master Files being transferred across a portfolio of clinical studies. The initial 30-day period will focus on triaging high-risk gaps and confirming that essential documentation is complete, accurate, and filed to the correct study. Follow-on work is expected to include remediation, outreach, tracking, and ongoing study-level TMF support. Key Responsibilities Perform detailed, document-level reviews of electronic Trial Master Files across multiple clinical studies. Use the TMF Reference Model and study-specific indexes to navigate artifacts, follow workstreams, and assess filing completeness. Confirm that documents are filed to the correct study and contain accurate study identifiers, titles, dates, and metadata. Identify missing, misfiled, duplicated, incomplete, or incorrectly indexed documents and clearly document findings. Support metadata correction, reclassification, filing cleanup, and other remediation activities. Prioritize urgent and inspection-critical gaps during the initial 30-day review window. Required Qualifications Hands-on experience working within electronic Trial Master Files; paper-file-only experience is not sufficient. Working knowledge of the TMF Reference Model and the ability to search, filter, and follow artifacts across functional workstreams without foundational training. Experience conducting TMF reviews, audits, quality checks, or inspection-readiness activities. Experience identifying document-level gaps and performing or coordinating metadata remediation. Ability to distinguish administrative and filing-quality issues from scientific-content review requirements. Strong attention to detail, sound judgment, and the ability to execute quickly against defined review criteria. Availability to begin quickly and operate effectively in a compressed, high-priority environment. Preferred Qualifications

CTA, TMF

Specialist, Clinical Documentation Specialist, or similar clinical operations experience in a sponsor or CRO environment. Experience supporting a regulatory inspection, mock inspection, audit, or formal inspection-readiness initiative. Experience with TMF transfers from a CRO to a sponsor and familiarity with common transfer-quality issues. Experience in small biotechnology organizations or lean, highly hands-on clinical operations teams. Exposure to major eTMF platforms; the specific source and destination systems remain to be confirmed. What Success Looks Like High-risk TMF gaps are surfaced early enough for action within the 30-day transfer-review window. Documents and metadata are accurately assessed, categorized, and remediated with minimal rework. Open items are tracked through resolution, with clear escalation of missing evidence and external dependencies. Maintain trackers and communicate findings, dependencies, and remediation status to TMF leadership. Coordinate follow-up with study teams, sites, CROs, and vendors to obtain missing or corrected documentation. Support longer-term TMF maintenance for active studies as needs evolve.