Job Description

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.

The Senior Manager, TMF Management is responsible for the strategic oversight, governance, administration, and continuous improvement of Alfasigma’s Trial Master File (TMF) framework across the clinical development portfolio. Acting as the company Subject Matter Expert (SME) for TMF processes and systems, this role ensures that study documentation is managed in accordance with regulatory requirements, industry best practices, and organizational standards.

The role serves as business owner and administrator for the Veeva eTMF platform, driving system excellence, compliance, and operational efficiency. Working closely with Clinical Operations, Clinical Excellence, Quality, IT, Study Teams, and external partners, the Senior Manager ensures robust TMF oversight, inspection readiness, and high-quality study records throughout the clinical trial lifecycle.

In addition, this position leads the TMF function and team, promoting a culture of quality, integrity, collaboration, and continuous improvement while supporting the achievement of departmental and organizational objectives.

Your Role

As Senior Manager, TMF Management, you will:

• Serve as Alfasigma’s Subject Matter Expert and business owner for TMF processes, governance, and the Veeva eTMF platform.
• Define and implement the strategic roadmap for TMF management, driving future-state improvements, innovation, and operational excellence.
• Lead and develop the TMF team, fostering a high-performance culture focused on compliance, quality, and continuous improvement.
• Oversee TMF quality management activities, including metrics reporting, periodic reviews, issue management, CAPA follow-up, and compliance monitoring against internal procedures and regulatory expectations.
• Ensure inspection readiness through effective TMF oversight and maintenance of complete, accurate, and contemporaneous study documentation.
• Partner with Quality, IT, and system stakeholders to support validation activities, change control processes, and system integrity within the Veeva eTMF environment.
• Provide strategic oversight of TMF-related activities performed by CROs and external vendors, ensuring adherence to quality and compliance standards.
• Develop and deliver TMF training, guidance, and best practices to internal teams and external partners.
• Collaborate with Operational Team Leads, Study Team Leads, and cross-functional stakeholders to ensure consistent TMF execution across clinical programs.
• Contribute to broader Clinical Excellence initiatives and support key departmental projects as required.

Who You Are

You are an experienced clinical operations professional with deep expertise in Trial Master File management, quality systems, and clinical trial documentation. You combine strategic thinking with strong operational execution and are passionate about driving inspection readiness, process excellence, and team development in a highly regulated environment.

Requirements

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences, or another health-related discipline; Master's degree is a plus.
• Minimum 10 years of experience in clinical research within a pharmaceutical, biotechnology, CRO, or life sciences environment.
• At least 5 years of direct TMF management experience, including oversight of electronic TMF systems.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical trial documentation requirements. Knowledge of EMA and other international regulations is advantageous.
• Proven experience in quality management and project management within GxP-regulated environments.
• Demonstrated people leadership and line management experience, with a track record of building, coaching, and developing high-performing teams.
• Experience overseeing CROs and external service providers.
• Strong expertise in Veeva eTMF or comparable electronic TMF platforms.
• Excellent communication, stakeholder management, and influencing skills across global and cross-functional teams.
• Professional certification such as PMP and/or Quality Auditing is considered a plus.
• Fluent English, both written and spoken.

Key Competencies

• Strategic leadership and people development
• TMF governance and inspection readiness
• Clinical trial documentation management
• Quality and compliance mindset
• Process optimization and continuous improvement
• Vendor and CRO oversight
• Cross-functional collaboration and stakeholder engagement
• Analytical thinking and problem-solving
• Change management and organizational agility

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.