Requirements: English
Company: IQVIA Italia
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. JOBDESCRIPTION: To ensure data management and statistics trialdocumentation is managed according to internal standards andregulatory requirements To oversee activities to ensure TMFdocumentation is published in a timely manner and with high qualityin order to maintain TMF in an inspection and audit readiness Tolead the Documentation and Data Archiving team providing subjectmatter expertise and guidance to team members To ensure providersmatch performance expectations To promote optimal use of tools andmetrics related to documentation management RESPONSIBILITIES: Tolead the documentation and data archiving team, recruiting,mentoring and developing the teamTo train DM/STAT CRO on Companystandards and TMF related activity To monitor TMF relatedactivities using metrics to evaluate status and gaps to ensurequality and timelines and evaluate corrective actions To supportteam members in the TMF plan activities and quality checks Toparticipate to audit and inspection to TMF To perform regularchecks on data archiving activities to ensure timelines arerespected To contribute to eTMF process improvement and internalsystem development REQUIREMENTS AND SKILLS: Scientific degree Asignificant experience in a similar job in the industry or CROKnowledge of drug development process Solid knowledge of clinicaldata management and statistical process and related documentation,standards and tools Strong knowledge of international standards forTrial Master File (TMF Reference Model) Knowledge of ICH GCP andregulatory requirements with specific reference to data integrity,data archiving and document management Good knowledge of SAS SystemKnowledge of international data standards (CDISC) and regulatoryrequirements for data submission Project and budget managementEnglish knowledge eTMF - EDMS - SAS System TYPE OF CONTRACT:Maternity replacement Chemical contract IQVIA reserves the right toevaluate candidates with domicile / residence and work experience /study with requirements responding to the open request.Applications WITHOUT the requirements Will NOT be fully taken intoaccount. Please enter the authorization for the processing ofpersonal data (DL196/2003) - General Data Protection Regulation (13GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAsClients. The research is urgent and is intended for candidates ofboth sexes (L.903/77).