Festus. O

Etmf Specialist @TransPerfect

US

Leading client engagements and consistently deliver quality customer successOwn and account for the TMF for our clients, across multiple studies and programsSupport inspection readiness as a culture, and compliance with Good Clinical Practices (GCP) regulatory requirementsAssist study teams with all start up, maintenance and close out activities in regards to the TMFSet up eTMF system requirements (configuration, eTMF Index, expected documents, users etc.)eTMF ongoing user managementCreate study specific TMF PlansEnsure TMF plan complianceEnsure compliance with client Standard Operating Procedures (SOPs) and work instructionsMeet with study teams to understand events/activities that would impact the TMFMay be responsible for creation and or maintenance of events/placeholders or equivalent in the eTMFDrive TMF queries to resolutionComplete TMF quality reviews at agreed intervals and ensure documentation is present/complete in the TMFIdentify and report to study leads on TMF trending issues/concerns, determining resolutions and course of actionsIdentify continuous improvement opportunities to enhance TMF operational efficienciesMonitor and assess the overall health of the TMFProvide support and guidance to study teams to drive performance against TMF Key Performance Indicators (KPIs)- completeness, quality and timeliness, using reports and metricsTraining, feedback and support to study teams to build knowledge and awareness of good document management practicesStoryboard creation and maintenance to assist with inspection readinessSupport Audits/Inspections as neededComplete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

Lagos State University

Bachelor of Science - BS, Biology, General