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 IQVIA's Clients. The research is urgent and is intended for candidates of both sexes (L.903/77).