E-TMF Specialist

Social network you want to login/join with: Job Title: 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 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 development. Train DM/STAT CRO on company standards and TMF activities. Monitor TMF activities using metrics to evaluate status, identify gaps, and ensure quality and timeliness, implementing corrective actions as needed. 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 adherence to timelines. 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. Strong understanding of clinical data management, statistical processes, documentation standards, and tools. Expertise in international standards for Trial Master File (TMF Reference Model). Knowledge of ICH GCP and regulatory requirements, especially related to data integrity, archiving, and document management. Proficiency with SAS System. Understanding of international data standards (CDISC) and data submission regulations. Experience in project and budget management. Proficiency in English. Familiarity 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 studies aligning with the requirements. Applications lacking the required qualifications will not be fully considered. Candidates must consent to the processing of personal data under DL196/2003 and GDPR 679/16. This urgent search is open to all genders (L.903/77). J-18808-Ljbffr

Location: savona, IT

Posted Date: 6/17/2025