BioNTech SE · 5 days ago
Senior Manager, Trial Master File
Cambridge, MA
Full-time
Onsite
Senior Level
$131K/yr - $201K/yr
5+ years expBioNTech SE is a leading biopharmaceutical company focused on innovative therapies. The Senior Manager, Trial Master File is responsible for overseeing the quality and compliance of the Trial Master File for clinical trials, ensuring audit readiness and collaboration with cross-functional teams.
Health Care
Responsibilities
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
Qualification
Required
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
Benefits
Medical, Dental and Vision Insurance
Life, AD&D, Critical Illness Insurance
Pre-tax HSA & FSA, DCRA Spending Accounts
Employee Assistance & Concierge Program (EAP) available 24/7
Parental and Childbirth Leave & Family Planning Assistance
Sitterstream: Virtual Tutoring & Childcare Membership
Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
401(K) Plan with Company Match
Tuition Reimbursement & Student Loan Assistance Programs
Wellbeing Incentive Platforms & Incentives
Professional Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
Company
BioNTech SE
At BioNTech we understand that every cancer patient’s tumor is unique and therefore each patient’s treatment should be individualized.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
James Ryan
Chief Legal Officer and Chief Business Officer
Recent News
2025-10-21
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