TMF Team Lead

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gd17u

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a TMF Team Lead based in Italy.

This role offers the opportunity to lead critical Trial Master File operations within a global clinical research environment.
You will ensure inspection readiness, compliance, and high-quality document management across multiple clinical studies.
The position combines operational leadership, quality oversight, and collaboration with international project teams and stakeholders.
You will play a key role in maintaining regulatory standards while improving processes and supporting successful clinical trial delivery.
Working with multidisciplinary teams, you will use data-driven insights and strong organizational skills to manage complex documentation activities.
This is an impactful opportunity for a detail-oriented professional who wants to contribute to advancing healthcare and improving patient outcomes.

Accountabilities:

The TMF Team Lead will oversee Trial Master File operations,



ensuring compliance with regulatory requirements, internal procedures, and industry best practices. This role requires strong leadership, analytical thinking, and the ability to collaborate with global teams to maintain document quality and inspection readiness.
- Lead and support the delivery of TMF services across multiple clinical studies.
- Ensure Trial Master Files remain inspection-ready and compliant with applicable regulations, procedures, and ALCOA principles.
- Perform Records Management Compliance (RMC) oversight activities and monitor documentation quality.
- Track key performance indicators and communicate performance insights to project teams and external stakeholders.
- Identify operational risks, develop mitigation strategies, and support continuous improvement initiatives.
- Analyze TMF data and apply insights to drive informed, data-based decisions.
- Develop and maintain project-specific Quality Management Doc

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gd17u