E-TMF Specialist

Social network you want to login/join with: Job Opportunity: eTMF Specialist On behalf of our client, a global pharmaceutical company, IQVIA is seeking an eTMF Specialist to join an exciting and dynamic 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, maintaining inspection and audit readiness. Lead the Documentation and Data Archiving team, providing expertise and guidance. 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 development. Train DM/STAT CRO teams on company standards and TMF activities. Monitor TMF activities using metrics to evaluate status, identify gaps, and implement corrective actions. Support team members in TMF planning and quality checks. Participate in audits and inspections of TMF. Regularly check data archiving activities to ensure timelines are respected. Contribute to eTMF process improvements and system development. Requirements and Skills: Significant experience in a similar role within the industry or CRO. Knowledge of the drug development process. Strong understanding of clinical data management, statistical processes, documentation, standards, and tools. In-depth knowledge of international standards for Trial Master File (TMF Reference Model). Knowledge of ICH GCP and regulatory requirements, especially concerning data integrity, archiving, and document management. Proficiency with SAS System. Familiarity with international data standards (CDISC) and data submission regulations. Project and budget management skills. Proficiency in English. Experience with eTMF, EDMS, SAS System. Contract Details: This position is a maternity replacement contract within the chemical sector. IQVIA reserves the right to evaluate candidates based on domicile/residence, work experience, and qualifications aligned with the role. Applications lacking the required qualifications will not be fully considered. Candidates must authorize the processing of personal data according to GDPR (Regulation 679/16). This research is urgent and open to candidates of all genders (L.903/77). J-18808-Ljbffr

Location: rovigo, IT

Posted Date: 6/15/2025