Sr. Manager, TMF Management

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Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.
Over three years ago, we embarked on a transformative journey to become

a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health . We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.
But our journey is far from complete

In fact, this is just the beginning of a bold new chapter in Alfasigma's history.



We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.
Scope of the Role

The Senior Manager, TMF Management is accountable for the oversight, governance, administration, and continuous improvement of Alfasigma’s Trial Master File (TMF) processes and systems across the clinical development portfolio. Acting as the company’s subject matter expert for TMF management and the Veeva eTMF platform, this role ensures the completeness, quality, inspection readiness, and compliance of study documentation throughout the clinical trial lifecycle.
The position partners closely with Clinical Operations, Study Team Leads, Operational Team Leads (OTLs), Quality, IT, and external partners to maintain robust TMF processes, ensure regulatory compliance, drive operational excellence, and support successful study execution. The role also leads the TMF team, promotes a cult

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/89qebl