About the role

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
Skills & Tags
go gcp ai ios data

Aplyr's read

BridgeBio Pharma is a dynamic biotechnology firm dedicated to tackling genetic diseases and cancers, attracting professionals passionate about impactful medical advancements.
Synthesized from recent postings & public sources

What's promising

•BridgeBio focuses on innovative treatments for genetic diseases, offering significant potential for groundbreaking medical advancements.
•The company has a robust pipeline with multiple late-stage clinical trials, indicating strong future growth prospects.
•BridgeBio's strategic partnerships enhance its research capabilities and expand its therapeutic reach.

What to watch

•The company faces high financial risk due to significant R&D expenditures without guaranteed success.
•BridgeBio operates in a highly competitive market with numerous established players.
•Regulatory hurdles for drug approvals can delay product launches and impact revenue.

Why BridgeBio Pharma

•BridgeBio's focus on genetic diseases and cancers sets it apart in the biotechnology sector.
•The company's decentralized model allows for nimble and efficient project management.
•BridgeBio's commitment to rare diseases addresses unmet medical needs, differentiating its mission.

Aplyr’s read is generated by AI from public sources. Was it useful?