[Hiring] Senior Manager, TMF Management @Alfasigma

Role Description

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

• 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.

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.

Key Competencies

• 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).

Benefits

• Competitive salary.
• Comprehensive benefits.
• Extensive opportunities for professional growth and development.