Requirements: English
Company: IQVIA Italia
Region: Parma , Emilia-Romagna
On behalf of our Client a global pharmaceutical company, IQVIA is looking for a eTMF Specialist who can join an exciting working environment in a dynamic atmosphere.RESPONSIBILITIES: To adhere to eTMF SOP and other relevant TMF process supporting guidance, acting as eTMF Key-user for Clinical Trial Supply sectionsCentral person to support processes, tools, and culture of the eTMF system for Clinical Trial SupplyEXECUTION AND COMPLIANCEAcquisition of documents in the eTMF and perform quality control (Investigational products and Clinical Trial Supply sections) using the company systemReview eTMF Plan of clinical studiesMonitoring of any anomalies and deviations of the eTMF system and involvement of the relevant functions (internal Company / CMO / CRO) until their resolution.Support to external users of the eTMF system (CMO) on the use of the sameSupport in the preparation of the study-specific RFP in relation to CTS eTMF services, if necessary.Archiving of documentation relating to CTS activities in the corporate CTS repositoryOperate according to cGMP, Company SOPs and Policies and Guidelines to accomplish daily tasksSupport Quality Investigations for Deviations and ComplaintsSupport Change Control EvaluationCollaborate to the identification of root cause analysis related to Departments processes and tools Support GCD Clinical Operations during audits and/or regulatory Inspections in relation to TMF related matters Support for activities related to clinical trials CTS (packaging, labelling and distribution)PROJECT GOVERNANCEContribute to the definition of the Department strategyCollaborate with the CS Lead in the setup of CTS Documents Mapping for each Clinical StudyThe role is part of the eTMF Committee who governs standards and policies to maintain the TMF and ensure alignment with process and business requirements.SOPS, GUIDELINES, WORKING INSTRUCTIONS AND TRAININGAuthoring SOPs, Guidelines and Working InstructionsReviewing SOPs, Guidelines and Working InstructionsProvide training on the job to Junior personnel and the CS Lead on specific topics related to eTMF system and documents managementSupport Department self-evaluationSupport Competent Authorities (CAs) GMP and GCP inspectionsINNOVATION AND TECHNOLOGYThe role will help the Department improvement to develop and keep standards and policies to maintain the TMF and ensure alignment with CTS processes. The role contributes to the changes and updates to the eTMF system interacting with the eTMF vendor and necessary activities to keep the system in a validated state.The role helps to raise and maintain awareness across the organization of changes in the eTMF landscape, including both regulatory requirements and industry trendsPropose sustainable and technological innovation related the eTMF documents managementREQUIREMENTS AND SKILLS: Scientific degreeA significant experience in a similar job in the industry or CRODemonstrated proficiency with TMF Management. Comprehensive practical knowledge of TMF processes, related standards and its quality control Working knowledge of clinical research documentsThorough understanding of ICH-GCP quality standards and other relevant regulations as applicable to management of clinical documentationGood knowledge of investigational medicinal products regulations and clinical operation processesGood knowledge of GMPNet-working and team workingAction and results driven Orientation toward efficiencyOrientation toward the clientsAbility to manage stressIntuitive skillsCapable of analysing, resuming and interpreting informationCapable of planning and anticipating actions according to priorities and deadlines Capable of working efficiently with various teamsCapable of creating and maintaining good relations Fluent EnglishTYPE OF CONTRACT: Maternity replacementChemical contractIQVIA reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).