Sr. Manager, TMF Management

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pSelect how often (in days) to receive an alert: /ppAlfasigma 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. /ppOver three years ago, we embarked on a transformative journey to become ba truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health /b. 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. /ppbBut our journey is far from complete! /b 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. /ph3Scope of the Role /h3pThe 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. /ppThe 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. /ph3Your Role /h3pAs Senior Manager, TMF Management, you will: /pulliServe as Alfasigma’s TMF Subject Matter Expert (SME), system owner, and business administrator for the Veeva eTMF platform. /liliDefine, implement, and continuously improve TMF business processes, standards, governance, and strategy. /liliLead and develop the TMF team, fostering a culture of quality, integrity,



accountability, and operational excellence. /liliEnsure TMFs are maintained in a state of ongoing inspection readiness and in compliance with applicable regulations, SOPs, and industry best practices. /liliMonitor TMF health and performance through metrics, quality reviews, periodic audits, and compliance assessments. /liliIdentify, track, and oversee the timely resolution of TMF-related issues, deviations, queries, and CAPAs. /liliPartner with Clinical Operations teams to provide expert guidance on TMF planning, document management, filing quality, and study closeout activities. /liliCollaborate with Quality, IT, and system stakeholders to ensure appropriate system validation, change control, and governance processes are maintained. /liliProvide oversight of TMF activities performed by CROs and external vendors to ensure quality and compliance standards are met. /liliSupport process improvement initiatives, inspection preparedness activities, and Clinical Excellence programs across the organization. /liliDevelop and deliver TMF-related training, guidance, and best practices to internal teams and external partners. /liliContribute to departmental objectives and strategic initiatives in alignment with business priorities. /li /ulh3Who You Are /h3h3Experience Qualifications /h3ulliBachelor's degree in a scientific, life sciences, healthcare, or related discipline; Master's degree is an advantage. /liliMinimum 10 years of experience in clinical research within pharmaceutical, biotechnology, CRO, biomedical, or life sciences organizations. /liliAt least 5 years of experience in Trial Master File (TMF) management. /liliProven people leadership and line management experience. /liliExperience in quality management and project management within a GxP-regulated environment. /liliCRO oversight experience is strongly preferred. /liliPMP certification and/or Quality Audit certifications are considered a plus.



/li /ulh3Technical Expertise /h3ulliDeep expertise in TMF management, study documentation, and clinical trial operations. /liliStrong knowledge of GCP, ICH guidelines, FDA regulations, and global clinical research requirements. /liliFamiliarity with EMA, CHMP, and other international regulatory frameworks is highly desirable. /liliDemonstrated experience administering and supporting Veeva eTMF and related document management systems. /liliAdvanced proficiency with Microsoft Office applications and electronic document management platforms. /liliAbility to translate technical requirements into business processes and communicate complex concepts effectively. /liliStrong leadership, coaching, and team development capabilities. /liliExcellent communication and stakeholder management skills across all organizational levels. /liliDemonstrated problem-solving, root cause analysis, and decision-making abilities. /liliStrong organizational skills with the ability to manage multiple priorities in a fast-paced environment. /liliHigh attention to detail and a commitment to quality and compliance. /liliAbility to influence cross-functional teams and build collaborative relationships. /liliAdaptability and resilience in changing business environments. /liliStrong written and verbal communication skills with the ability to present ideas, processes, and recommendations clearly. /liliAbility to work effectively across different geographies, cultures, and time zones. /liliSelf-directed, proactive, and results-oriented mindset. /liliWillingness to travel internationally as required (typically less than 10% annually). /li /ulpLocation: Europe or US (East Coast) /ph3Why Join Alfasigma: /h3pbAt Alfasigma, we foster a culture where the courage to innovate is key to our success. /bbr/We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. /ppOur 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. /ppbJoin Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry. /b /p #J-18808-Ljbffr

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