Requirements: English
Company: IQVIA Italia
Region: Palermo , Sicily
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 audit readiness
- To lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team members
- 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 reserves the right to evaluate candidates with domicile / residence and work experience / study with requirements responding to the open request. Applications WITHOUT the requirements Will NOT be fully taken into account. Please enter the authorization for the processing of personal data (DL196/2003) - General Data Protection Regulation (13 GDPR 679/16 ) to IQVIA and to transfer those data to IQVIAs Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).