Global TMF Lead & Clinical Operations Manager

Alfasigma; Bologna; In loco; EUR 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

Alfasigma is seeking a Senior Manager, TMF Management to oversee TMF processes and the Veeva eTMF platform across the clinical portfolio. You will ensure documentation is inspection-ready, compliant with GxP and regulatory standards, and aligned with company objectives.

You will lead a TMF team, collaborate with Clinical Operations, Quality, and IT, and drive continuous improvement in TMF governance and performance.

Competenze

• Minimum 10 years of experience in clinical research within pharmaceutical, biotechnology, CRO, biomedical, or life sciences organizations.
• At least 5 years of experience in Trial Master File (TMF) management.
• Proven people leadership and line management experience.
• Experience in quality management and project management within a GxP-regulated environment.
• CRO oversight experience is strongly preferred.

Mansioni

• Serve as Alfasigma’s TMF SME, system owner, and business administrator for the Veeva eTMF platform.
• Define, implement, and continuously improve TMF business processes, standards, governance, and strategy.
• Lead and develop the TMF team, fostering a culture of quality, integrity, accountability, and operational excellence.
• Ensure TMFs are maintained in a state of ongoing inspection readiness and in compliance with applicable regulations, SOPs, and industry best practices.
• Monitor TMF health and performance through metrics, quality reviews, periodic audits, and compliance assessments.
• Identify, track, and oversee the timely resolution of TMF-related issues, deviations, queries, and CAPAs.
• Partner with Clinical Operations teams to provide expert guidance on TMF planning, document management, filing quality, and study closeout activities.
• Collaborate with Quality, IT, and system stakeholders to ensure appropriate system validation, change control, and governance processes are maintained.
• Provide oversight of TMF activities performed by CROs and external vendors to ensure quality and compliance standards are met.
• Support process improvement initiatives, inspection preparedness activities, and Clinical Excellence programs across the organization.
• Develop and deliver TMF-related training, guidance, and best practices to internal teams and external partners.
• Contribute to departmental objectives and strategic initiatives in alignment with business priorities.

Conoscenze

TMF management

Veeva eTMF

GxP-regulated

Stakeholder management

Leadership

Formazione

Bachelor's degree

Master's degree

Strumenti

Veeva eTMF

Microsoft Office

EDMS

Descrizione del lavoro

Alfasigma is seeking a Senior Manager, TMF Management to oversee TMF processes and the Veeva eTMF platform across the clinical portfolio. You will ensure documentation is inspection-ready, compliant with GxP and regulatory standards, and aligned with company objectives.

You will lead a TMF team, collaborate with Clinical Operations, Quality, and IT, and drive continuous improvement in TMF governance and performance.