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Associate Director Tmf Jobs (NOW HIRING)

BridgeBio Pharma

Associate Director, TMF Operations Lead

$34.25 - $46.75/hr

... direct industry experience in lieu of education will be considered Experience & Skills: * 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience ...

BridgeBio Pharma

Associate Director, TMF Operations Lead

$34.25 - $46.75/hr

... direct industry experience in lieu of education will be considered Experience & Skills: * 8+ years of experience in TMF Operations, Clinical Operations, or Clinical Quality, including experience ...

Cabaletta Bio

This role ensures oversight of controlled documentation, training, vendor quality, TMF health, and inspection readiness. The Associate Director drives compliance across GxP functions, integrating ...

Ocugen Inc

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required). * Working knowledge of the DIA TMF ...

Ocugen Opco Inc

TMF Lead

Malvern, AR · On-site

$29.25 - $40/hr

Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required).Working knowledge of the DIA TMF Reference ...

OCUGEN OPCO INC

TMF Lead

Malvern, PA · On-site

$32.75 - $45/hr

Hands-on experience managing TMF from study startup through closeout and archival, including direct experience with the Veeva Vault eTMF system (required). * Working knowledge of the DIA TMF ...

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How much do associate director tmf jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for associate director tmf in the United States is $39.99, according to ZipRecruiter salary data. Most workers in this role earn between $32.21 and $43.99 per hour, depending on experience, location, and employer.

What are the roles and responsibilities of an Associate Director TMF?

An Associate Director TMF (Trial Master File) is responsible for overseeing the management, quality, and compliance of TMF documentation in clinical trials. They ensure that all essential documents are collected, maintained, and archived according to regulatory requirements and company policies. The role often includes leading TMF teams, developing SOPs, training staff, and collaborating with cross-functional teams to support inspection readiness. Associate Directors also monitor TMF metrics, conduct audits, and implement process improvements to ensure efficient and compliant TMF operations.

What skills and qualifications are needed to thrive as an Associate Director TMF?

To excel as an Associate Director TMF (Trial Master File), you need in-depth knowledge of clinical trial documentation, regulatory requirements, and quality management principles, typically supported by a degree in life sciences or a related field. Familiarity with electronic TMF systems (eTMF), GCP guidelines, and industry-standard document management software is crucial. Exceptional organizational skills, attention to detail, and effective leadership and communication abilities set top performers apart. These skills ensure the integrity, compliance, and efficiency of clinical trial documentation, which is vital for successful regulatory submissions and trial outcomes.

What are the typical responsibilities and team interactions for an Associate Director TMF within a clinical research organization?

As an Associate Director TMF (Trial Master File), you will oversee the management and quality of TMF documentation to ensure compliance with regulatory standards. Your daily responsibilities often include leading TMF strategy, supervising document management teams, coordinating with clinical project managers, and supporting audits or inspections. Collaboration is key in this role, as you work closely with cross-functional teams such as clinical operations, quality assurance, and regulatory affairs to ensure seamless documentation processes. This position also offers opportunities to mentor team members and drive process improvements, contributing to both personal and organizational growth.

What is the difference between Associate Director Tmf vs Clinical Trial Manager?

AspectAssociate Director TmfClinical Trial Manager
Required CredentialsBachelor's or higher in life sciences, often with experience in TMF managementBachelor's or higher in life sciences, with clinical trial management experience
Work EnvironmentPharmaceutical or biotech companies, overseeing TMF processesClinical research sites or sponsors managing trial operations
Employer & Industry UsageUsed in pharmaceutical and biotech industries for TMF oversightCommon in clinical research organizations and sponsors for trial execution

The Associate Director Tmf primarily focuses on overseeing Trial Master File processes and compliance, often in a strategic capacity, while the Clinical Trial Manager handles the day-to-day management of clinical trials. Both roles require strong knowledge of clinical trial operations, but the Associate Director Tmf emphasizes document oversight and regulatory adherence, whereas the Clinical Trial Manager concentrates on trial execution and site management.

What are popular job titles related to Associate Director Tmf jobs?

For Associate Director Tmf jobs, the most frequently searched job titles are:

Infographic showing various Associate Director Tmf job openings in the United States as of September 2026, with employment types broken down into 1% As Needed, 68% Full Time, 28% Part Time, 1% Temporary, 1% Contract, and 1% Nights. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution, with an average salary of $83,169 per year, or $40 per hour.

Associate Director, TMF Operations Lead

Remote

BridgeBio Pharma
Biotechnology Research and Development • 201 - 500 employees
Learn more about BridgeBio Pharmaexternal

$34.25 - $46.75/hr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 18 days ago

Job description

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.
Who You Are
ML Bio Solutions is searching for an experienced TMF Operations Lead to develop and implement the strategy for ensuring completeness and accuracy of the TMF for all BBP-418 clinical trials. This individual will establish and lead the TMF strategy across the BBP-418 clinical development program, ensuring inspection readiness through proactive oversight, quality management, and cross-functional collaboration. This individual will serve as the TMF Subject Matter Expert, driving process improvements, overseeing CRO performance, and fostering a culture of TMF excellence that aligns with ICH-GCP, regulatory expectations, and company standards.
What you will do
  • 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

Education, Experience & Skills Requirements
  • 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

Experience & Skills:
  • 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

Other:
  • Travel - Remote candidates must be willing to travel for company meetings for a minimum of one week per quarter; travel for team and/or study meetings may be required
  • Role level will be filled commensurate with experience

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
$191,000-$220,000 USD
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 BridgeBio Full-Time U.S 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

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