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 âmoneyball for biotechâ 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 experimentationâincluding 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
Bachelorâs degree in life sciences, health sciences, or a related field (or equivalent experience)
2â5+ 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
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary$115,000—$145,000 USDAs 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, âtake-what-you-needâ 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
Apply Now
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 âmoneyball for biotechâ 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 experimentationâincluding 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
Bachelorâs degree in life sciences, health sciences, or a related field (or equivalent experience)
2â5+ 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
At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.
Salary$115,000—$145,000 USDAs 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, âtake-what-you-needâ 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
Apply Now