Requirements: English
Company: IQVIA Italia
Region: Pisa , Tuscany
On behalf of our Client a global pharmaceutical company, IQVIA is looking for aeTMF Specialistwho can join an exciting working environment in a dynamic atmosphere.JOB DESCRIPTION:To ensure data management and statistics trial documentation is managed according to internal standards and regulatory requirementsTo oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and audit readinessTo lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team membersTo ensure providers match performance expectationsTo promote optimal use of tools and metrics related to documentation managementRESPONSIBILITIES:To lead the documentation and data archiving team, recruiting, mentoring and developing the teamTo train DM/STAT CRO on Company standards and TMF related activityTo monitor TMF related activities using metrics to evaluate status and gaps to ensure quality and timelines and evaluate corrective actionsTo support team members in the TMF plan activities and quality checksTo participate to audit and inspection to TMFTo perform regular checks on data archiving activities to ensure timelines are respectedTo contribute to eTMF process improvement and internal system developmentREQUIREMENTS AND SKILLS:Scientific degreeA significant experience in a similar job in the industry or CROKnowledge of drug development processSolid knowledge of clinical data management and statistical process and related documentation, standards and toolsStrong knowledge of international standards for Trial Master File (TMF Reference Model)Knowledge of ICH GCP and regulatory requirements with specific reference to data integrity, data archiving and document managementGood knowledge of SAS SystemKnowledge of international data standards (CDISC) and regulatory requirements for data submissionProject and budget managementEnglish knowledgeeTMF - EDMS - SAS SystemTYPE 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).