Trial Master File Jobs in USA with Visa Sponsorship
Trial Master File specialists manage the regulatory document backbone of clinical trials, making them a consistent hire at pharmaceutical companies, CROs, and biotech firms that routinely sponsor H-1B and TN visas. A degree in life sciences, health informatics, or a related field typically satisfies specialty occupation requirements for this role.
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Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families, and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn, and Facebook.
Role Summary
The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end-to-end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high-quality clinical execution, and operate efficiently at scale. This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance.
Primary Responsibilities Include
TMF Strategy & Leadership:
- Define and own the company’s TMF strategy, including innovation opportunities and continuous improvement initiatives
- Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals
- Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends
- Represent TMF leadership in cross-functional forums, governance committees, and senior-level operational discussions
Governance & Process Ownership:
- Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards
- Oversee TMF lifecycle management—from planning and setup through closeout and archival
- Define TMF roles, responsibilities, and RACI structures across internal teams and vendors
- Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues
- Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners
TMF Oversight & Compliance:
- Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs)
- Ensure TMFs across the portfolio remain inspection ready
- Lead TMF-related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate
- Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities to implement proactively
Vendor & Technology Management:
- Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements
- Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations
- Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF
- Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices
Cross Functional Partnership & Support:
- Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations
- Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements
- Advise leadership on TMF health and organizational readiness for key regulatory events
Education And Skills Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred
- 8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise
- Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations
- Proven experience developing TMF strategy, governance frameworks, or enterprise-level processes
- Ability to lead cross-functionally without authority
- Demonstrated leadership in managing TMF operations or oversight at a portfolio level
- Experience working with eTMF systems and CRO/vendor oversight
- Excellent communication, influencing, and stakeholder management skills
MA Pay Range
$155,000 - $190,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as a preclinical program for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families, and communities. Learn more at https://www.dyne-tx.com/, and follow us on X, LinkedIn, and Facebook.
Role Summary
The Associate Director, Trial Master File (TMF) Lead is responsible for developing and driving the global TMF strategy, establishing and maintaining robust governance frameworks, and ensuring end-to-end oversight of the Trial Master File across the clinical portfolio. This role serves as the enterprise owner of TMF processes, quality standards, and inspection readiness, ensuring that TMF operations meet regulatory requirements, support high-quality clinical execution, and operate efficiently at scale. This role partners closely with Clinical Operations, Quality, Regulatory, and external vendors to ensure a unified, proactive approach to TMF health, completeness, and compliance.
Primary Responsibilities Include
TMF Strategy & Leadership:
- Define and own the company’s TMF strategy, including innovation opportunities and continuous improvement initiatives
- Lead the development and implementation of scalable TMF operating models, ensuring alignment with clinical development goals
- Serve as the internal subject matter expert on TMF best practices, regulations, and inspection trends
- Represent TMF leadership in cross-functional forums, governance committees, and senior-level operational discussions
Governance & Process Ownership:
- Establish and maintain TMF governance frameworks, including policies, SOPs, work instructions, and quality standards
- Oversee TMF lifecycle management—from planning and setup through closeout and archival
- Define TMF roles, responsibilities, and RACI structures across internal teams and vendors
- Monitor adherence to processes and drive corrective and preventive actions (CAPAs) related to TMF quality issues
- Ensure timely collection, review, and management of TMF documents from clinical study teams and external partners
TMF Oversight & Compliance:
- Provide strategic oversight of TMF operations, including ongoing quality reviews, completeness assessments, and key performance indicators (KPIs)
- Ensure TMFs across the portfolio remain inspection ready
- Lead TMF-related preparation for audits, inspections, and regulatory submissions, ensuring all documentation is complete and accurate
- Analyze TMF metrics and trends to proactively identify risks, gaps, and improvement opportunities to implement proactively
Vendor & Technology Management:
- Oversee TMF service providers, CRO partners, and technology platforms to ensure alignment with TMF requirements
- Partner with IT and business stakeholders to optimize the eTMF system, workflows, and integrations
- Ensure vendors adhere to contractual obligations, performance expectations, and quality standards related to TMF
- Stay up to date with industry trends and regulatory requirements related to TMF management and documentation practices
Cross Functional Partnership & Support:
- Collaborate with cross-functional study teams to guide TMF planning, milestones, and document management expectations
- Provide training, coaching, and strategic direction to internal and external partners on TMF processes and regulatory requirements
- Advise leadership on TMF health and organizational readiness for key regulatory events
Education And Skills Requirements
- Bachelor’s degree in life sciences or related field; advanced degree preferred
- 8+ years of experience in clinical operations, document management, or related GxP environment, with significant TMF expertise
- Strong knowledge of ICHGCP, TMF Reference Model, and global regulatory expectations
- Proven experience developing TMF strategy, governance frameworks, or enterprise-level processes
- Ability to lead cross-functionally without authority
- Demonstrated leadership in managing TMF operations or oversight at a portfolio level
- Experience working with eTMF systems and CRO/vendor oversight
- Excellent communication, influencing, and stakeholder management skills
MA Pay Range
$155,000 - $190,000 USD
The pay range reflects the base pay range Dyne reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-related knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
How to Get Visa Sponsorship in Trial Master File
Target CROs and pharma companies first
Contract research organizations like ICON, Parexel, and Syneos Health, along with major pharmaceutical companies, sponsor TMF roles regularly. These employers have established immigration infrastructure and sponsor H-1B and TN workers far more consistently than smaller biotech startups.
Highlight your DIA Reference Model knowledge
Familiarity with the DIA TMF Reference Model signals immediate productivity to hiring managers. Employers sponsoring visas want reduced onboarding time, and demonstrating hands-on experience with TMF structure standards makes you a lower-risk hire worth sponsoring.
Certify your eTMF platform experience
Proficiency in electronic TMF systems such as Veeva Vault or Documentum is increasingly expected. Listing specific platforms on your resume and quantifying inspection-readiness outcomes you achieved strengthens your specialty occupation case and improves your sponsorship prospects significantly.
Understand the specialty occupation argument
USCIS requires that your role normally requires a bachelor's degree in a specific field. For TMF specialists, framing your position around regulatory affairs, clinical data management, or health informatics rather than general administration strengthens the H-1B specialty occupation determination considerably.
Canadians and Mexicans should explore TN status
TN visa classification under USMCA covers scientific technicians and certain clinical roles. If your background is in life sciences or health records management, TN status offers a faster, cap-exempt alternative to H-1B with no lottery risk and same-day border processing available.
Use Migrate Mate to filter sponsoring employers
Not every clinical operations job comes with sponsorship. Migrate Mate lists TMF roles specifically from employers with documented H-1B sponsorship history, letting you focus your applications on companies already set up to support your visa rather than discovering that late in the process.
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Get Access To All JobsFrequently Asked Questions
Do Trial Master File jobs qualify for H-1B sponsorship?
Yes, TMF specialist roles generally qualify as H-1B specialty occupations when they require a bachelor's degree in a specific field such as life sciences, health informatics, regulatory affairs, or clinical research. The critical factor is how the employer defines the position. Roles framed around regulatory compliance and clinical documentation management are stronger candidates than those described as general administrative work. Your employer's HR and legal team will determine the exact specialty occupation argument filed with USCIS.
What degree do I need for visa sponsorship in a TMF role?
Most employers require a bachelor's degree in life sciences, health information management, clinical research, pharmacy, or a closely related field. Degrees in biology, biochemistry, or public health are commonly accepted. A general business or administrative degree is less likely to satisfy USCIS specialty occupation requirements for this role, so degree-field alignment matters. Some employers also accept equivalent combinations of education and direct TMF or regulatory experience when the degree field isn't a perfect match.
Is the TN visa an option for TMF specialists from Canada or Mexico?
It can be, depending on how the role is classified. TN visa categories covering scientific technicians, pharmacists, or clinical laboratory technologists may apply if your educational background and job duties align. TN status has no lottery, no cap, and can be processed at the border for Canadians. However, TN classification is occupation-specific and must fit a defined USMCA category, so confirming the match with your employer's immigration counsel before applying is important.
Which types of employers are most likely to sponsor TMF roles?
Large contract research organizations, global pharmaceutical companies, and mid-size biotechs with active clinical pipelines sponsor TMF positions most consistently. These employers have experienced immigration teams and established processes for H-1B filing. Smaller startups in early-stage development sometimes sponsor but may lack the legal infrastructure for a smooth process. Browse Migrate Mate to find TMF roles specifically from employers with a track record of visa sponsorship.
How does the H-1B lottery affect my chances of getting sponsored for a TMF job?
The regular H-1B cap has a selection rate that has ranged from roughly 25% to 50% in recent years, meaning sponsorship isn't guaranteed even if an employer is willing to file. TMF roles at cap-exempt employers, such as nonprofit research institutions or university-affiliated hospitals, bypass the lottery entirely. If you're already in the U.S. on OPT or another H-1B, a change of employer doesn't require a new lottery selection, which makes your candidacy more straightforward for sponsoring companies.
What is the prevailing wage requirement for sponsored Trial Master File jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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