Associate Director, TMF Operations Lead

BridgeBio

TMF Operations Lead at BridgeBio Pharma ensuring Trial Master File compliance and inspection readiness across clinical trials. Collaborating cross-functionally, leading improvements in TMF processes and governance.

Posted 7/24/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $191,000 - $220,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Trial Master File (TMF) operations, ensuring compliance with ICH-GCP guidelines and regulatory requirements while leading inspection readiness activities. Proven ability to develop and improve TMF processes, manage cross-functional collaborations, and analyze performance metrics to enhance operational effectiveness.

Highest-signal resume keywords

TMF OperationsICH-GCP ComplianceClinical Trial Document ManagementTMF Reference Model StructureMicrosoft Excel Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TMF OperationsClinical OperationsClinical QualityALCOA+ StandardsGood Documentation PracticesPerformance Metrics AnalysisRisk AssessmentCAPA DevelopmentTMF Process ImprovementDrug Development Life Cycle

Soft Skills

Strong Communication SkillsProblem-SolvingCritical ThinkingAttention to DetailAdaptability

Tools & Technologies

Microsoft WordMicrosoft PowerPointSmartsheetSharePoint

Industry Keywords

Trial Master FileInspection ReadinessClinical TrialsRegulatory RequirementsCRO Oversight

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead TMF operations across assigned clinical studies, ensuring timely, complete, and inspection-ready Trial Master File documentation in compliance with ICH-GCP, regulatory requirements, and company standards.
Establish TMF governance across the clinical development program by monitoring TMF health, quality metrics, risk assessments, and inspection readiness, and communicating key findings to study teams and leadership.
Develop, maintain, and continuously improve TMF processes and governing documents, including TMF Plans, TMF Indexes, SOPs, guidance documents, and CRO TMF Oversight Plans.
Partner with Clinical Operations, Regulatory, Data Management, Medical Writing, Quality Assurance, and external vendors to ensure timely document filing, issue resolution, and consistent execution of TMF processes.
Provide strategic oversight of CRO-managed TMF activities through performance metrics, governance meetings, quality reviews, issue escalation, and continuous improvement initiatives.
Lead TMF inspection readiness activities, including ongoing quality reviews, health assessments, audit support, inspection preparation, artifact retrieval, and CAPA development and follow-up.
Identify TMF compliance risks and quality trends, develop mitigation strategies, and drive corrective and preventive actions to maintain a state of continuous inspection readiness.
Serve as the TMF Subject Matter Expert by providing strategic guidance, delivering training, mentoring study teams, and representing TMF Operations on cross-functional initiatives.
Analyze TMF performance metrics and vendor quality outputs to identify trends, recommend process improvements, and strengthen operational effectiveness across the development program.
Foster a culture of TMF excellence through knowledge sharing, lessons learned, and implementation of innovative approaches to improve TMF quality and efficiency

Requirements

What you’ll need

Minimum Education requirement: University degree qualified or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related degree or more than 8 years extensive experience in similar roles and proven track record; direct industry experience in lieu of education will be considered
8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience supporting global clinical trials
Understanding of the drug development life cycle
Experience in handling clinical trial-related documents required
Strong knowledge of Trial Master File Reference Model Structure standard and country-level documents
Demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices
Demonstrated ability to achieve high-performance goals and meet deadlines in a fast-paced environment
Excellent organizational skills and possess high standards and great attention to detail
Strong communication skills – verbal and written
Highly conscientious and takes initiative to efficiently resolve issues
Must be resourceful and adaptable to support multiple competing demands and changing priorities
Proven successes in problem-solving, strong decision-making, critical thinking, and conflict management
Must be proficient in Microsoft Excel, Word, and PowerPoint, and familiar with Smartsheet and SharePoint

Benefits

Comp & perks

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
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