SR. Trial Master File Specialist

Mavericks Wanted 

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on 
  
In 2015, we pioneered a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.  
  
Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation—including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work. 

Job Summary

The Clinical Trial Master File (TMF) Specialist is responsible for the ongoing maintenance, quality control, and oversight of the Trial Master File to ensure inspection readiness and compliance with applicable regulatory requirements (e.g., ICH-GCP, FDA, EMA). This role supports clinical trial teams by managing TMF documents throughout the study lifecycle and ensuring timely, accurate, and complete filing.

Key Responsibilities

TMF Management & Maintenance

• Maintain the electronic Trial Master File (eTMF) in accordance with ICH-GCP, regulatory requirements, and internal SOPs
• Ensure timely collection, processing, indexing, and filing of essential documents
• Perform ongoing TMF quality control (QC) checks for completeness, accuracy, currency, and consistency
• Track missing, incomplete, or late documents and follow up with internal teams, CROs, vendors, and sites

Quality & Compliance

• Conduct periodic TMF health checks and reconcile TMF content against expected document lists
• Support TMF review cycles, audits, and inspection readiness activities
• Identify TMF risks, trends, and gaps; propose and implement corrective actions
• Ensure documents meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)

Cross-Functional Collaboration

• Serve as a TMF subject matter expert for study teams, CROs, and functional partners
• Support TMF-related training for internal staff and external partners
• Participate in study startup, maintenance, and close-out activities from a TMF perspective

Process Improvement & Reporting

• Generate TMF metrics, dashboards, and status reports
• Contribute to TMF process improvements, SOP updates, and inspection readiness initiatives
• Support implementation or optimization of eTMF systems and workflows

Required Qualifications

• Bachelor’s degree in life sciences, health sciences, or a related field (or equivalent experience)
• 2–5+ years of experience in clinical trials, TMF management, or clinical operations
• Strong working knowledge of ICH-GCP and global regulatory requirements
• Experience with eTMF systems (e.g., Veeva Vault eTMF, Wingspan, MasterControl, TMF Reference Model)
• Excellent attention to detail and document quality standards

As a global company, our comprehensive benefits may vary based on location.  We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For USA based roles:

Financial & Rewards  

• Market-leading compensation   

• 401(k) with employer match   

• Employee Stock Purchase Program (ESPP)  

• Pre-tax commuter benefits (transit and parking)  

• Referral bonus for hired candidates  

• Subsidized lunch and parking on in-office days  

Health & Well-Being  

• 100% employer-paid medical, dental, and vision premiums for you and your dependents  

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)  

• Fertility & family-forming benefits  

•  Expanded mental health support (therapy and coaching resources)  

• Hybrid work model with flexibility  

• Flexible, “take-what-you-need” paid time off and company-paid holidays  

• Comprehensive paid medical and parental leave to care for yourself and your family  

Skill Development & Career Paths: 

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility 

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching 

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities