Senior Clinical Trial Manager Jobs in USA with Visa Sponsorship
Senior Clinical Trial Manager roles attract strong H-1B visa and O-1 visa sponsorship from large pharmaceutical companies, CROs, and academic medical centers. These positions require a life sciences degree and direct trial oversight experience, which satisfies specialty occupation requirements with minimal pushback from USCIS. For detailed occupation requirements, see the O*NET profile.
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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.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Senior Clinical Trial Manager
Target CROs and large pharma sponsors first
Contract research organizations like ICON, Labcorp Drug Development, and Syneos Health sponsor visas regularly and have established immigration processes. Large pharma companies with dedicated HR immigration teams move faster and make fewer errors on petitions.
Document your GCP training and protocol experience
USCIS will scrutinize whether your background directly supports a specialty occupation. A portfolio of GCP certifications, IRB submissions, and protocol deviation reports strengthens the specialty occupation argument beyond your degree alone.
Clarify your monitoring versus management scope early
Senior CTM roles involve budget oversight, vendor management, and cross-functional leadership, not just site monitoring. Make sure your job offer letter and employer support letter reflect the full scope, which directly supports the H-1B specialty occupation determination.
Ask about cap-exempt sponsorship if working near academia
CTM roles at academic medical centers and nonprofit research institutions can qualify for cap-exempt H-1B filings. This bypasses the lottery entirely, giving you a direct path to approval without waiting for the annual registration window.
Consider O-1A if you have published research or regulatory achievements
Senior CTMs with published clinical research, regulatory submissions as a named contributor, or speaking engagements at major conferences like DIA may qualify for O-1A. It has no cap, no lottery, and is employer-filed without labor certification.
Use Migrate Mate to find confirmed sponsoring employers
Not every company that posts a Senior CTM role will sponsor visas. Migrate Mate filters job listings to show employers who have an active sponsorship track record, saving you from spending weeks applying to companies that will reject you at the offer stage.
Frequently Asked Questions
Does a Senior Clinical Trial Manager role qualify as a specialty occupation for H-1B purposes?
Yes, Senior CTM roles consistently qualify as specialty occupations because the position normally requires at least a bachelor's degree in a life sciences, nursing, pharmacy, or related field. USCIS has approved petitions for this title across pharma and CRO employers. The key is that the employer's job description must state a degree in a specific field is required, not merely preferred.
Which visa types are most common for Senior Clinical Trial Managers?
H-1B visa is by far the most common. TN visas are an option for Canadian and Mexican nationals with a relevant life sciences degree. O-1A is increasingly viable for CTMs who have published research, served on FDA advisory panels, or held leadership roles in major industry organizations. L-1 visa applies if you're transferring within a multinational CRO or pharma company from a foreign office.
Do I need a master's degree or PhD to get sponsored as a Senior CTM?
No, a bachelor's degree in a qualifying field is sufficient for H-1B sponsorship in most cases. However, a master's or PhD strengthens your petition, particularly if your undergraduate field is not a direct match for the role. Some employers require an advanced degree for senior-level positions, so check individual job descriptions carefully before applying.
How selective are pharmaceutical companies about sponsoring Senior CTMs compared to junior roles?
Pharma companies and CROs are generally more willing to sponsor at the senior level because the role is harder to fill domestically and the business case is easier to justify. Senior CTMs with Phase II or Phase III oncology or rare disease trial experience are especially sought after. That said, sponsorship decisions vary by employer, so use Migrate Mate to identify companies with a documented history of sponsoring this role.
Can a Senior CTM role at a university hospital qualify for a cap-exempt H-1B?
Yes, if the academic medical center qualifies as a nonprofit research organization or is affiliated with a university, the H-1B petition may be filed cap-exempt. This means no lottery, no registration window, and the ability to file any time of year with a relatively fast processing timeline. Confirm the institution's cap-exempt status with their HR or legal team before counting on this pathway.
What is the prevailing wage requirement for sponsored Senior Clinical Trial Manager 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.