Madrigal Pharmaceuticals · 2 days ago
Senior Director, Trial Master File (TMF) Operations
Conshohocken, PA
Full-time
Onsite
Director/Executive
15+ years expMadrigal Pharmaceuticals is a biopharmaceutical company dedicated to combating metabolic dysfunction-associated steatohepatitis (MASH). They are looking for a Senior Director of Trial Master File (TMF) Operations to oversee the creation and management of an in-house TMF document management system, ensuring quality compliance and strategic direction across the Research and Development Department.
BiopharmaBiotechnologyMedical DevicePharmaceutical
Responsibilities
Provide leadership and strategic direction across the R&D Department, with specific focus on the Clinical Management Department, to ensure the TMF processes and related documentation are of the highest quality for active in-house and outsourced studies by drawing experience w/ quality compliance processes and regulations such as Good Clinical & Documentation Practices
Adhere to ALCOA-CCEA principles (i.e. records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring & Available)
Develop standard reporting for ongoing compliance check by study to be presented at the Clinical study team meetings and to management
Grow and lead a team of direct reports, commensurate with the business requirements, that will support the TMF platforms and each study TMF
Develop proactive approaches to process improvements and enhancements of TMF
Author and review internal and external TMF-related SOPs, work instruction development and procedural documents as well as TMF Plans and associated documentation (e.g., TMF indexes/mapping, risk-based QC processes etc.) including working with the cross functional study team to obtain necessary input
Ensure inspection ready TMF and provide expert support for audits and inspections
Instill a culture of continuous improvement; acts as a change champion and effectively leads change
Manage the TMF processes to meet the goals and objectives of the department and maintain inspection readiness for all active studies
Create and lead training across all relevant business units/functional areas on business processes around Clinical Document Management and the Trial Master File, eTMF system(s), and quality oversight of vendors
Development and oversight of management and maintenance of TMF repositories, including supporting filing, scanning, QC, and inventory of paper documents
Partner with IT and internal clinical business operations resources to support the strategic lifecycle of TMF including, but not limited to, version releases, system updates, validation or user acceptance testing, and integrations with other clinical applications through change management
Support study teams at the end of trial eTMF QC and migration activities, including study documents from all vendors
Drive the development and reporting of metrics and KPIs related to inspection readiness, quality, TMF completeness, and performance
Ad hoc support of activities within the Clinical Management team to help meet timelines and objectives including support with archiving, document collection and processing, and/or start-up activities as needed
Apply knowledge of ICH-GCP, Code of Federal Regulations (CFR), and other national and local requirements to develop and improve document management processes
Other duties as assigned
Qualification
Required
Bachelor's Degree or higher
15+ years experience successfully leading the TMF activities for a clinical research organization (CRO) and/or in the biotech/pharmaceutical industry; other relevant experience will be considered
Leadership skills and experience managing employees and contractors
Knowledge of applicable TMF and Document Management regulations and guidelines such as CFR Part 11, MHRA and EMA
Experience with Inspection Readiness
Thorough knowledge of ICH-GCP guidelines and applicability to all stages of the clinical development process
Excellent attention to accuracy and details
Effective written and verbal communication skills
Excellent presentation skills, providing information to a large audience
Strong software and computer skills, including Microsoft Office applications (Word, Excel, Outlook)
Outstanding organizational skills with the ability to multi-task and prioritize in a fast-paced environment
Ability to learn new technologies with ease
Solid analytical and proactive problem-solving skills
Strong operational skills and demonstrated ability to meet timelines
A team player with ability to build relationships at all levels
Demonstrated self-starter with a high level of commitment
Preferred
Experience with Veeva eTMF platform, strongly preferred
Experience with CDISC Trial Master File Reference model and good understanding of records management best practices
Hands-on experience in a regulatory body inspection, strongly preferred
Benefits
Flexible paid time off
Medical, dental, vision and life/disability insurance
401(k) offerings (i.e., traditional, Roth, and employer match)
Supplemental life insurance
Legal services
Mental health benefits through our Employee Assistance Program for employees and their family
Company
Madrigal Pharmaceuticals
Madrigal Pharmaceuticals is a biopharmaceutical company developing therapeutics for the treatment of cardiovascular-metabolic diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.94BKey Investors
Blue OwlHercules Capital
2025-07-22Post Ipo Debt· $350M
2024-03-18Post Ipo Equity· $690M
2023-09-28Post Ipo Equity· $500M
Leadership Team
Mardi C. Dier
Chief Financial Officer
Carole Huntsman
Chief Commercial Officer (CCO)
Recent News
2026-01-19
Company data provided by crunchbase