Clinical Research Associate Specialist

2 giorni fa

Provincia di Reggio nell'Emilia, Italia IQVIA Italia A tempo pieno

On behalf of our Client - Chiesi Farmaceutici, one of the top 50 pharmaceutical companies in the world, with more than 80 years of experience within the pharmaceutical and biotechnology industry a global pharmaceutical company - IQVIA is looking for a eTMF Specialist who can join an exciting working environment in a dynamic atmosphere.

This position will oversee the global eTMF (electronic Trial Master File) operations for GRD R&D including providing support to all study teams members involved in eTMF management. This position will assume the leadership role for global eTMF operation to ensure the quality KPIs are met and eTMFs are inspection ready at all times.

Establish KPIs and metrics for documents filed in the eTMF to improve performance, quality, risk mitigation and contingency planning.
Accountable to ensure consistency in eTMF management at all stages (eTMF set-up, maintenance, QC/ QR and query management, final reconciliation, closure, migration and archiving).
Supports the team on gap analysis/ verification activities on TMFs acquired through acquisition.
BS/BA in Life Sciences or similar discipline
Minimum 5 years of experience in similar position in Pharmaceutical or CRO industry and in R&D environment
Extensive experience managing eTMF including set-up, maintenance, QC/QR and query management, final reconciliation, migration and archiving
Demonstrated proficiency in written, verbal and face-to-face communication to effectively present information to and influence decision making of managers, working partners (local and global), and government agencies
Proficient in MS Office (Word, Excel, Outlook, Project and PowerPoint) and Adobe; TYPE OF CONTRACT:
Chemical Contract permanent


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.

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