The primary focus will be TMF review, site-level reconciliation, remediation and inspection readiness . The initial review must be completed within an aggressive 30-day window, so the consultant must be able to contribute immediately with limited training. Responsibilities Conduct detailed review of eTMF documentation with particular focus on site-level artifacts and inspection readiness. Assess TMF completeness, accuracy and quality rather than simply confirming that documents are present. Identify missing, incorrect, misfiled or inconsistent study/site documentation. Reconcile monitoring documentation, including monitoring reports, confirmation letters, follow-up letters, outstanding actions and evidence of issue resolution. Evaluate whether expected site-level essential documents have been collected and appropriately filed. Identify documentation gaps and determine their criticality and potential inspection risk . Distinguish high-priority compliance issues requiring immediate remediation from lower-risk administrative findings. Support remediation and follow-up activities associated with identified gaps. Partner with the TMF lead, Clinical Operations, IT and other stakeholders during the study-transfer review. Support inspection-readiness assessments, audits and/or mock inspection activities as needed. Qualifications Approximately 5+ years of CRA/clinical monitoring experience preferred ; Strong understanding of TMF/eTMF and site-level essential documentation. Must have personally performed meaningful TMF reviews. Experience supporting regulatory inspections, inspection-readiness activities, mock inspections and/or clinical audits . Strong understanding of GCP and clinical documentation requirements. Ability to assess findings using a risk-based/criticality-based approach . Strong experience reviewing site documentation and monitoring records. Sponsor experience preferred, although strong CRO candidates are acceptable. Able to work independently and immediately in a fast-paced remediation environment.