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 visa 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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Get Access To All JobsINTRODUCTION
Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.
Position Summary
The eTMF Associate is responsible for supporting the management, quality, completeness, and inspection readiness of the electronic Trial Master File (eTMF) across clinical development programs. This role collaborates with internal study teams, CROs, and vendors to ensure essential clinical trial documentation is filed accurately, timely, and in accordance with ICH-GCP, regulatory requirements, and company procedures.
Primary Responsibilities
- eTMF Management
- Support eTMF deliverables throughout the study lifecycle, from study start-up through closeout.
- Review and file clinical trial documents in the appropriate eTMF locations in accordance with the TMF Reference Model.
- Ensure documents are complete, accurate, version controlled, and contemporaneous.
- Monitor eTMF quality and completeness metrics and address filing gaps.
- Inspection Readiness
- Support ongoing TMF health checks and quality reviews.
- Assist with inspection-readiness activities and preparation for regulatory inspections and audits.
- Support tracking and resolution of TMF findings, quality issues, and overdue documents.
-
Support CAPA implementation related to TMF activities as applicable.
-
Clinical Operations Support
- Collaborate with Clinical Trial Managers, Clinical Study Associates, CROs, and vendors to obtain required documentation.
- Support study start-up, maintenance, and closeout documentation activities.
- Participate in study team meetings and provide TMF status updates.
-
Assist with the tracking of essential documents, training records, and study-specific deliverables.
-
Vendor and CRO Collaboration
- Coordinate document collection and filing activities with CROs and external vendors.
- Ensure vendor-generated documentation is received and filed according to established timelines.
-
Support reconciliation activities between the CRO TMF and sponsor eTMF.
-
Process Improvement and Compliance
- Follow company SOPs, work instructions, and regulatory requirements.
- Contribute to the development and improvement of TMF processes and tools.
- Support TMF-related training activities for internal and external stakeholders.
-
Assist with document migration, archival, and system-related initiatives as needed.
-
Deliver on other related projects as assigned.
Qualifications
- Education and Certification
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related scientific discipline, or Associate degree + relevant experience.
- Work Experience
- 1–3 years of experience in clinical research, document management, quality, or clinical operations.
- Experience working with an eTMF system preferred (e.g., Veeva Vault eTMF, Trial Interactive, Wingspan, Florence, or equivalent).
- Understanding of the Trial Master File structure and ICH-GCP requirements.
-
Biotech, pharmaceutical, or CRO experience preferred.
-
Skills and Key Success Factors
- Entrepreneurial spirit with a passion to build, learn and evolve with the team
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values and ethical standards
Other Relevant Information
- Travel: able to travel globally up to 20% of time
Compensation
- Base Salary Range: $55,000 - $75,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
- Discretionary Bonus: up to 5% of Base Salary, contingent upon meeting performance components
- Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.
Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.
INTRODUCTION
Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.
Position Summary
The eTMF Associate is responsible for supporting the management, quality, completeness, and inspection readiness of the electronic Trial Master File (eTMF) across clinical development programs. This role collaborates with internal study teams, CROs, and vendors to ensure essential clinical trial documentation is filed accurately, timely, and in accordance with ICH-GCP, regulatory requirements, and company procedures.
Primary Responsibilities
- eTMF Management
- Support eTMF deliverables throughout the study lifecycle, from study start-up through closeout.
- Review and file clinical trial documents in the appropriate eTMF locations in accordance with the TMF Reference Model.
- Ensure documents are complete, accurate, version controlled, and contemporaneous.
- Monitor eTMF quality and completeness metrics and address filing gaps.
- Inspection Readiness
- Support ongoing TMF health checks and quality reviews.
- Assist with inspection-readiness activities and preparation for regulatory inspections and audits.
- Support tracking and resolution of TMF findings, quality issues, and overdue documents.
-
Support CAPA implementation related to TMF activities as applicable.
-
Clinical Operations Support
- Collaborate with Clinical Trial Managers, Clinical Study Associates, CROs, and vendors to obtain required documentation.
- Support study start-up, maintenance, and closeout documentation activities.
- Participate in study team meetings and provide TMF status updates.
-
Assist with the tracking of essential documents, training records, and study-specific deliverables.
-
Vendor and CRO Collaboration
- Coordinate document collection and filing activities with CROs and external vendors.
- Ensure vendor-generated documentation is received and filed according to established timelines.
-
Support reconciliation activities between the CRO TMF and sponsor eTMF.
-
Process Improvement and Compliance
- Follow company SOPs, work instructions, and regulatory requirements.
- Contribute to the development and improvement of TMF processes and tools.
- Support TMF-related training activities for internal and external stakeholders.
-
Assist with document migration, archival, and system-related initiatives as needed.
-
Deliver on other related projects as assigned.
Qualifications
- Education and Certification
- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Public Health, or related scientific discipline, or Associate degree + relevant experience.
- Work Experience
- 1–3 years of experience in clinical research, document management, quality, or clinical operations.
- Experience working with an eTMF system preferred (e.g., Veeva Vault eTMF, Trial Interactive, Wingspan, Florence, or equivalent).
- Understanding of the Trial Master File structure and ICH-GCP requirements.
-
Biotech, pharmaceutical, or CRO experience preferred.
-
Skills and Key Success Factors
- Entrepreneurial spirit with a passion to build, learn and evolve with the team
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating complex concepts for various audiences
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highest levels of professionalism, confidence, personal values and ethical standards
Other Relevant Information
- Travel: able to travel globally up to 20% of time
Compensation
- Base Salary Range: $55,000 - $75,000, with the actual contingent upon several factors such as the selected candidate’s education/work experience/training, and other factors (travel requirements, etc.)
- Discretionary Bonus: up to 5% of Base Salary, contingent upon meeting performance components
- Benefits: Eligible to participate in group medical/dental/vision insurance plans; short- and long-term disability plans; life insurance; 401(K) plan; flexible time off policies and others. Eligibility and participation requirements vary by plan.
Alkeus Pharmaceuticals, Inc. is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We participate in E-Verify and conduct background checks as a part of our employment process.
See all Trial Master File Jobs
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Get Access To All JobsTips for Finding Trial Master File Jobs
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.
Frequently Asked Questions
Do Trial Master File jobs qualify for H-1B sponsorship?
Yes, TMF specialist roles generally qualify as H-1B visa 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.