Senior Manager, Trial Master File

Role Summary

Senior Manager, Trial Master File.

Location:

New Jersey, US;
Cambridge, US;
Gaithersburg, US. Full-time role overseeing the quality, completeness, and accuracy of the Trial Master File (TMF) for BioNTech-sponsored clinical trials, ensuring regulatory compliance and inspection readiness.

• Provide technical expertise in the management of both paper and electronic Trial Master Files (TMF), ensuring compliance with ICH/GCP guidelines, regulatory requirements and internal policies
• Support inspection readiness initiatives by maintaining TMF documentation that is audit-ready and aligned with industry standards
• Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, and Quality Assurance, to ensure TMF deliverables are completed accurately and within established timelines
• Partner with Contract Research Organizations (CROs) to oversee TMF-related activities, resolve challenges and ensure alignment with project objectives
• Develop and implement a framework to evaluate the overall health of the TMF, focusing on quality, completeness and timeliness
• Conduct regular reviews and audits of the electronic TMF (eTMF) for all BNT-sponsored clinical trials
• Identify gaps in TMF documentation and collaborate with BNT trial teams to implement corrective actions and achieve compliance goals
• Mentor and develop TMF team members, sharing knowledge and fostering a high-performance culture focused on quality and accountability

• University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 5 years extensive experience in similar roles with a proven track record
• At least five (5) years of pharmaceutical industry or drug development experience with a minimum of three (3) years TMF experience required, including experience in study start-up, maintenance, and closeout, and performing quality and completeness reviews
• Broad experience across TMF lifecycle management (start-up, maintenance, closeout, archiving) and a solid understanding of clinical trial processes
• Proven ability to lead TMF initiatives across cross-functional, global teams and provide strategic oversight of TMF operations
• Demonstrated leadership in preparing for and participating in TMF audits and inspections, including health authority interactions
• Experience working with and overseeing TMF vendors and CROs to ensure compliance and performance
• Expert-level knowledge of TMF management frameworks, including TMF Reference Model, ALCOA+ principles, Good Documentation Practices (GDP), and ICH-GCP (E6), as well as familiarity with applicable regulatory frameworks such as 21 CFR Part 11
• Proven ability to serve as a Subject Matter Expert (SME) in TMF systems, ideally including extensive experience with Veeva Vault eTMF
• Experience with TMF governance, metrics, inspection readiness, and continuous process improvement
• Demonstrated ability to develop and maintain TMF-related SOPs, training programs, and cross-functional procedural alignment
• Strong analytical and decision-making skills, capable of interpreting TMF data and identifying trends and risks
• Excellent written and verbal communication skills, with the ability to influence, negotiate, and build partnerships at all levels across internal and external stakeholders
• High level of accountability, attention to detail, and the ability to operate with independence in a high-paced, matrixed environment
• Proficiency in Microsoft Office and other clinical systems, with ability to quickly adapt to new tools and platforms

• Background check will be conducted as part of the recruitment process