Etmf and Data Archiving

2 mesi fa

Parma, Italia Novasyte A tempo pieno

On behalf of our Client a global pharmaceutical company, IQVIA is looking for a eTMF and Data Archiving 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 audit 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

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

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