Trial Master File (TMF) Specialist

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.
 
Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com 

Who You Are

Reporting to the Senior Manager, TMF Operations, the TMF Specialist is an important study team member working closely with Clinical Operations and Quality Assurance on ensuring a high quality and complete eTMF for our ongoing clinical trials.  With the ultimate objective of constant inspection readiness for a pivotal program, the TMF Specialist, as an individual contributor, will be responsible for supporting the processes outlined in the TMF Plans, and associated processes/documents, established for our studies (at QED and the CRO) to support timely, accurate, and complete submission of documents to the eTMF by all study team representatives, as well as supporting overall eTMF activities. The TMF Specialist is a vital link between the day-to-day operations of the clinical project and the ultimate collection of documentation providing evidence of applicable compliance to regulatory authorities’ requirements and expectations. The TMF Specialist plays an integral role in the quality control review of all TMF documents, in support of the Senior Manager, TMF Operations. 

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 

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills 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 
• Preferred:
• 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 

What We Offer

• 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. Learn more about how we do this here
• 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