E-tmf Specialist

3 giorni fa

Milano, Italia IQVIA A tempo pieno

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a eTMF Specialist who can join an exciting working environment in a dynamic atmosphere.

JOB DESCRIPTION:

- To ensure data management and statistics trial documentation is managed according to internal standards and regulatory requirements;
- To oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and au-dit readiness;
- To ensure providers match performance expectations;
- To promote optimal use of tools and 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 Company standards and TMF related activity;
- To monitor TMF related activities using metrics to evaluate status and gaps to ensure quality and timelines and evaluate corrective actions;
- To support team members in the TMF plan activities and quality checks;
- To participate to audit and inspection to TMF;
- To perform regular checks on data archiving activities to ensure timelines are respected;
- To contribute to eTMF process improvement and internal system development.

REQUIREMENTS AND SKILLS.
- Scientific degree;
- A significant experience in a similar job in the industry or CRO;
- Knowledge of drug development process;
- Solid knowledge of clinical data management and statistical process 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 with specific reference to data integrity, data archiving and document management;
- Good knowledge of SAS System;
- Knowledge of international data standards (CDISC) and regulatory requirements for data submission;
- Project and budget management;
- English knowledge;
- eTMF - EDMS - SAS System.

TYPE OF CONTRACT:
Maternity replacement

Chemical contract

LI-CES #LI-DNP

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