Requirements: English
Company: IQVIA Italia
Region: Chieti , Abruzzo
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 toolsand metrics related to documentation management RESPONSIBILITIES: -To lead the documentation and data archiving team, recruiting,mentoring and developing the team - To 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 CRO -Knowledge of drug development process - Solid knowledge of clinicaldata management and statistical process and related documentation,standards and tools - Strong knowledge of international standardsfor Trial Master File (TMF Reference Model) - Knowledge of ICH GCPand regulatory requirements with specific reference to dataintegrity, data archiving and document management - Good knowledgeof SAS System - Knowledge of international data standards (CDISC)and regulatory requirements for data submission - Project andbudget management - English knowledge - eTMF - EDMS - SAS SystemTYPE 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).