Sr. Manager, TMF Management

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

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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 culture of quality and continuous improvement, and contributes to broader Clinical Excellence initiatives.

Your Role

As Senior Manager, TMF Management, you will:

• Serve as Alfasigma’s TMF Subject Matter Expert (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.

Who You Are

Experience & Qualifications

• Bachelor's degree in a scientific, life sciences, healthcare, or related discipline; Master's degree is an advantage.
• 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.
• PMP certification and/or Quality Audit certifications are considered a plus.

Technical Expertise

• Deep expertise in TMF management, study documentation, and clinical trial operations.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and global clinical research requirements.
• Familiarity with EMA, CHMP, and other international regulatory frameworks is highly desirable.
• Demonstrated experience administering and supporting Veeva eTMF and related document management systems.
• Advanced proficiency with Microsoft Office applications and electronic document management platforms.
• Ability to translate technical requirements into business processes and communicate complex concepts effectively.
• Strong leadership, coaching, and team development capabilities.
• Excellent communication and stakeholder management skills across all organizational levels.
• Demonstrated problem-solving, root cause analysis, and decision-making abilities.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• High attention to detail and a commitment to quality and compliance.
• Ability to influence cross-functional teams and build collaborative relationships.
• Adaptability and resilience in changing business environments.
• Strong written and verbal communication skills with the ability to present ideas, processes, and recommendations clearly.
• Ability to work effectively across different geographies, cultures, and time zones.
• Self-directed, proactive, and results-oriented mindset.
• Willingness to travel internationally as required (typically less than 10% annually).

Location: Europe or US (East Coast)

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.