E-TMF Specialist

Social network you want to login/join with: On behalf of our client, a global pharmaceutical company, IQVIA is seeking a eTMF Specialist to join a dynamic and exciting working environment. Job Description: Ensure data management and trial documentation are handled according to internal standards and regulatory requirements. Oversee activities to ensure TMF documentation is published timely and with high quality to maintain inspection and audit readiness. Lead the Documentation and Data Archiving team, providing expertise and guidance to team members. Ensure providers meet performance expectations. Promote optimal use of tools and metrics related to documentation management. Responsibilities: Lead the documentation and data archiving team, including recruiting, mentoring, and developing team members. Train DM/STAT CRO on company standards and TMF-related activities. Monitor TMF activities using metrics to evaluate status and identify gaps, ensuring quality and timelines, and implement corrective actions. Support team members in TMF planning activities and quality checks. Participate in audits and inspections related to TMF. Perform regular checks on data archiving activities to ensure timelines are respected. Contribute to eTMF process improvements and internal system development. Requirements and Skills: Significant experience in a similar role within the industry or CRO. Knowledge of the drug development process. Solid understanding of clinical data management, statistical processes, and related documentation, standards, and tools. Strong knowledge of international standards for Trial Master File (TMF Reference Model). Knowledge of ICH GCP and regulatory requirements, especially regarding data integrity, data archiving, and document management. Proficiency with SAS System. Knowledge of international data standards (CDISC) and data submission regulatory requirements. Experience in project and budget management. Proficiency in English. Experience with eTMF, EDMS, and SAS System. Type of Contract: Maternity replacement Chemical contract IQVIA reserves the right to evaluate candidates based on domicile/residence, work experience, and education to meet the open requirements. Applications lacking the required qualifications will not be fully considered. Please provide authorization for the processing of personal data (DL196/2003) and GDPR compliance (13 GDPR 679/16). The recruitment is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: provincia-di-palermo, IT

Posted Date: 6/16/2025