Trial Master File Specialist

Summary

Join QED Therapeutics, a BridgeBio Pharma affiliate, as a TMF Specialist and play a vital role in ensuring the quality and completeness of the electronic Trial Master File (eTMF) for ongoing clinical trials. Reporting to the Senior Manager, TMF Operations, you will collaborate with Clinical Operations and Quality Assurance. Responsibilities include implementing and managing record management processes, supporting TMF plan preparation, performing quality reviews, maintaining eTMF metrics, and addressing quality concerns. You will also support regulatory inspections and serve as a subject matter expert. This remote position, preferably based in the SF Bay Area, requires a Bachelor's degree in a scientific discipline or equivalent experience, along with 3-4 years of relevant experience in the biotech/pharmaceutical industry or CRO. The ideal candidate possesses strong organizational skills, attention to detail, and a positive team-oriented attitude.

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience
• Minimum of 3-4 years of biotech/pharmaceutical industry or contract research organization (CRO) experience
• Knowledge of the DIA TMF Reference Model and how documents from various functional areas map and meet TMF filing requirements
• Knowledgeable of Good Clinical Practice (GCP), and EU and FDA requirements for TMF content/structure, in relation to document quality control and review
• Experience managing TMF documents utilizing the TMF Reference Model
• Experience in conducting/managing TMF Quality Control activities
• Understanding of basic personal data privacy principles, Private Health Information, HIPPA, and GDPR protections for document content during quality control reviews
• Experience with managing large spreadsheets in MS Excel

Responsibilities

• Support the implementation and management of record management processes related to the electronic Trial Master File (eTMF) and ensure compliance with internal policies as well as external regulations
• With the Senior Manager, TMF Operations, serve as the operational process and subject matter representative to the clinical study team –researching and providing direction to team members on general and specific best practices in the documentation for clinical trials and presenting TMF status and expectations to the entire study team
• Support the preparation and management of TMF Plans and Content Lists – assuring study team and vendor compliance to plan and content list language – demands attention to detail, adequate or better application awareness of MS Excel and MS Word
• Support management of study eTMF setup, user access management, and document processing in eTMF system
• Perform eTMF quality reviews for Sponsor Oversight; identify document deficiencies and track them to resolution or rejection
• Maintain and report eTMF quality metrics for studies, create and edit reports and dashboards to facilitate study team awareness
• Direct and escalate quality-related concerns in gathered documentation
• Develop expert awareness of the filing structure and navigation of the system for continued inspection readiness and support, but also user support and education
• Demonstrates an interest and understanding of the BridgeBio community, clinical research, functional responsibilities, and continued professional development
• Oversee TMF quality for both the QED TMF and the CRO TMF across QED trials
• Facilitate the development and maintenance of the QED trial-specific Content Maps and Plans, Study Milestone Design and Expected Document Lists
• Identify, Facilitate and Adjudicate discussions of QED functional area TMF content accountability
• Facilitate QED TMF QC activities and track issues to completion
• Coordinate with CRO and study vendors to oversee the timely completion and resolution of issues from their QC activities
• Facilitate QED TMF system access requests/removal for team members
• Support activities related to ongoing TMF maintenance, close-out, transfer, and archival of study TMFs
• Support study teams during regulatory inspections and serve as subject matter expert (SME) for Regulatory Inspection activities

Preferred Qualifications

• Experience in working in CRO-owned eTMF system and User Access Management
• Previous participation with validation of electronic document management systems / eTMFs
• Excellent organizational skills, ability to manage multiple tasks and maintain meticulous attention to detail
• Experience with process implementation and management principles
• Can embrace the guiding principles of BridgeBio - #every-minute-counts, #let-science-speak, #put-patients-first, #think-independently, #radical-transparency
• Positive, team-oriented attitude a must
• Remote position; SF Bay Area based is preferred

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion