Minerva Casas Ventura Email & Phone Number

CLINICAL DOCUMENTATION MANAGEMENTSupport Set-up eTMF for each new study, prepare eTMF plan and update as appropriate during study in agreement with CRO and Almirall study team.Revision of all the RFP providing input to the eTMF related aspects. Make sure that all the documentation of the clinical studies that is uploaded into the eTMF is follows ALCOA+ principles.Follow up of the eTMF health by defining, adapting and following KPIs throughout the clinical study. Elaborate metrics on completeness and quality of TMF documentation, extract conclusions from them and take the appropriate relevant actions to address gaps, issues, and risks. Ongoing review of the reports and metrics.Ensure CRO is following the Quality Checks on eTMF documents at defined time points, including any paper originals required as per TMF plan.Provide input on the revision of TMF related Work Instructions and SOPs.Participate in the creation/harmonization of templates/guidance, e.g. document tracking tools, oversight tracking tools, training materials.Support Study Teams and other relevant TMF stakeholders in understanding their TMF-related responsibilities, requirements and expectations; act as an ad-hoc member of the Study Team.Work with CROs on agreed process for eTMF document transfer/delivery.Support Study Team in the maintenance of study documentation including paper files for those originals still required to be filed, if applicable.Support the Study Team in TMF document retrieval during Audits and InspectionsCoordinate and Maintain IT set-up of electronic server account for eTMF final export and proper central archiving of full eTMF.R&D CENTRAL ARCHIVE AND SCIENTIFIC INFORMATION MANAGEMENT Documentation custody in proper environmental conditionsManagement and maintenance of R&D Archive following SOPs and GXP in force. Management and administration of the scientific information.

Listed skills include Good Laboratory Practices, 21Cfr Part 11, Directivas Gamp, Microsoft Office, and 15 others.