Specialist, Regulatory
1 day ago
Validate document types, properties, indexing, and scanning quality against TMF readiness criteria and reference standards.
escalate risks/issues to the TMF Document Specialist Lead/TMF Operations as needed.
Operations, Training & Continuous Improvement
Deliver training/office hours for internal teams; Contribute to process improvements and special projects; 2–5+ years in TMF/eTMF operations within clinical research (CRO, sponsor, or TMF service provider).
~ Hands-on experience with Veeva Vault eTMF (or similar eTMF), including document ingestion, indexing, QC, and reporting.
~ Proven ability to run completeness reviews, manage EDL updates, and maintain inspection readiness .
~ Experience across Phase I–IV and multiple therapeutic areas.
experience building SOPs/work instructions.
completeness, timeliness, quality ).
Exposure to audit/inspection support (regulatory and sponsor).
Excel/Sheets for trackers & metrics).
Optional exposure: eCTD concepts, QMS, ETMF reporting/BI tools.
eTMF completeness % and quality error rate
Number of findings during internal QC/audits and regulatory inspections
Training adoption and stakeholder satisfaction
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