Requirements: English
Company: IQVIA Italia
Region: Reggio Emilia , Emilia-Romagna
On behalf of our Client a global pharmaceuticalcompany, IQVIA is looking for a eTMF Specialist who can join anexciting working environment in a dynamic atmosphere.RESPONSIBILITIES: - To adhere to eTMF SOP and other relevant TMFprocess supporting guidance, acting as eTMF Key-user for ClinicalTrial Supply sections - Central person to support processes, tools,and culture of the eTMF system for Clinical Trial Supply EXECUTIONAND COMPLIANCE - Acquisition of documents in the eTMF and performquality control (Investigational products and Clinical Trial Supplysections) using the company system - Review eTMF Plan of clinicalstudies - Monitoring of any anomalies and deviations of the eTMFsystem and involvement of the relevant functions (internal Company/ CMO / CRO) until their resolution. - Support to external users ofthe eTMF system (CMO) on the use of the same - Support in thepreparation of the study-specific RFP in relation to CTS eTMFservices, if necessary. - Archiving of documentation relating toCTS activities in the corporate CTS repository - Operate accordingto cGMP, Company SOPs and Policies and Guidelines to accomplishdaily tasks - Support Quality Investigations for Deviations andComplaints - Support Change Control Evaluation - Collaborate to theidentification of root cause analysis related to Departmentsprocesses and tools - Support GCD Clinical Operations during auditsand/or regulatory Inspections in relation to TMF related matters -Support for activities related to clinical trials CTS (packaging,labelling and distribution) PROJECT GOVERNANCE - Contribute to thedefinition of the Department strategy - Collaborate with the CSLead in the setup of CTS Documents Mapping for each Clinical Study- The role is part of the eTMF Committee who governs standards andpolicies to maintain the TMF and ensure alignment with process andbusiness requirements. SOPS, GUIDELINES, WORKING INSTRUCTIONS ANDTRAINING - Authoring SOPs, Guidelines and Working Instructions -Reviewing SOPs, Guidelines and Working Instructions - Providetraining on the job to Junior personnel and the CS Lead on specifictopics related to eTMF system and documents management - SupportDepartment self-evaluation - Support Competent Authorities (CAs)GMP and GCP inspections INNOVATION AND TECHNOLOGY - The role willhelp the Department improvement to develop and keep standards andpolicies to maintain the TMF and ensure alignment with CTSprocesses. The role contributes to the changes and updates to theeTMF system interacting with the eTMF vendor and necessaryactivities to keep the system in a validated state. - The rolehelps to raise and maintain awareness across the organization ofchanges in the eTMF landscape, including both regulatoryrequirements and industry trends - Propose sustainable andtechnological innovation related the eTMF documents managementREQUIREMENTS AND SKILLS: - Scientific degree - A significantexperience in a similar job in the industry or CRO - Demonstratedproficiency with TMF Management. - Comprehensive practicalknowledge of TMF processes, related standards and its qualitycontrol - Working knowledge of clinical research documents -Thorough understanding of ICH-GCP quality standards and otherrelevant regulations as applicable to management of clinicaldocumentation - Good knowledge of investigational medicinalproducts regulations and clinical operation processes - Goodknowledge of GMP - Net-working and team working - Action andresults driven - Orientation toward efficiency - Orientation towardthe clients - Ability to manage stress - Intuitive skills - Capableof analysing, resuming and interpreting information - Capable ofplanning and anticipating actions according to priorities anddeadlines - Capable of working efficiently with various teams -Capable of creating and maintaining good relations - Fluent EnglishTYPE OF CONTRACT: Maternity replacement Chemical contract IQVIAreserves the right to evaluate candidates with domicile / residenceand work experience / study with requirements responding to theopen request. Applications WITHOUT the requirements Will NOT befully taken into account. Please enter the authorization for theprocessing of personal data (DL196/2003) - General Data ProtectionRegulation (13 GDPR 679/16 ) to IQVIA and to transfer those datato IQVIAs Clients. The research is urgent and is intended forcandidates of both sexes (L.903/77).