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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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.
Role Summary
The Senior Clinical Trial Associate (CTA) is a key member of the Clinical Operations team responsible for supporting the successful planning, execution, oversight, and closeout of Dyne’s global clinical trials. This role partners closely with Clinical Study Leads, cross-functional study team members, CROs, vendors, and investigative sites to help ensure trials are delivered with quality, efficiency, compliance, and a strong focus on patients. The Senior CTA contributes to day-to-day study operations, maintains critical study documentation and tracking tools, supports inspection readiness, and helps establish scalable processes and best practices as Dyne continues to advance its clinical development portfolio. Success in this role requires strong organization, attention to detail, proactive communication, sound judgment, accountability, and the ability to manage competing priorities in a dynamic clinical development environment. This role is based in Waltham, MA.
Primary Responsibilities Include
- Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution, including feasibility, study planning, start-up, enrollment, maintenance, and closeout activities
- Partner with the Clinical Study Lead to facilitate effective communication across internal study teams, CROs, vendors, and other external partners, helping to proactively identify risks, resolve issues, and keep study activities on track
- Track study metrics, operational milestones, site activation progress, enrollment trends, vendor deliverables, and Sponsor oversight activities; work closely with CROs and vendors to ensure tracking tools are accurate, complete, and current
- Support the review, coordination, and quality control of essential study documents, including informed consent forms, site initiation visit materials, essential regulatory documents, study plans, recruitment materials, manuals, trackers, and other trial-related documents to ensure consistency, accuracy, and compliance
- Assist with the development, routing, distribution, and maintenance of Sponsor study documents and operational materials, such as protocols, protocol amendments, administrative letters, pharmacy manuals, study reference materials, and team communications
- Attend internal study team meetings and external CRO/vendor meetings; prepare and maintain agendas, meeting materials, minutes, decision logs, and action item trackers to support accountability and timely follow-through
- Coordinate logistics and materials for investigator meetings, principal investigator calls, site-facing communications, conferences, vendor meetings, and other study-related forums
- Collect, file, reconcile, and track essential documents for the trial master file (TMF); conduct routine TMF reviews, identify gaps, follow up on missing documentation, and support ongoing inspection readiness activities
- Take initiative to improve Clinical Operations processes by identifying opportunities for standardization, efficiency, quality, and continuous improvement within study teams and across the department
- Maintain and update study tracking tools, dashboards, contact lists, document logs, training records, and other operational resources to support transparency and timely decision-making
- Use sound judgment, intellectual curiosity, and a continuous improvement mindset to identify practical solutions, improve ways of working, and support consistent execution across study teams
- Communicate clearly and professionally with internal and external stakeholders, build effective working relationships, escalate issues appropriately, and follow through on commitments with urgency and attention to quality
Education And Skills Requirements
- Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent combination of education and relevant experience may be considered
- 3+ years of relevant hands-on clinical operations or drug development experience, preferably in a Sponsor setting and with exposure to global or multi-site clinical trials
- Working knowledge of clinical trial operations, ICH-GCP guidelines, regulatory requirements, TMF expectations, and inspection readiness principles
- Experience collaborating across multiple functional areas, such as Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Data Management, Biostatistics, Medical Writing, Clinical Supply, Finance, and external vendors
- Proficiency with clinical trial tracking systems, document management tools, Microsoft Office applications, and other systems used to support clinical trial execution and documentation
- Demonstrated ability to work independently, collaborate effectively within cross-functional teams, manage competing priorities, and deliver accurate, high-quality work with strong follow-through
- High level of professionalism, discretion, integrity, accountability, and alignment with Dyne’s values and commitment to patients
- Willingness to travel for job-related activities, including investigator meetings, site visits, conferences, or vendor meetings, if required (expected travel for this position is ~5%)
Compensation
- MA Pay Range: $86,000 - $105,000 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.
Role Summary
The Senior Clinical Trial Associate (CTA) is a key member of the Clinical Operations team responsible for supporting the successful planning, execution, oversight, and closeout of Dyne’s global clinical trials. This role partners closely with Clinical Study Leads, cross-functional study team members, CROs, vendors, and investigative sites to help ensure trials are delivered with quality, efficiency, compliance, and a strong focus on patients. The Senior CTA contributes to day-to-day study operations, maintains critical study documentation and tracking tools, supports inspection readiness, and helps establish scalable processes and best practices as Dyne continues to advance its clinical development portfolio. Success in this role requires strong organization, attention to detail, proactive communication, sound judgment, accountability, and the ability to manage competing priorities in a dynamic clinical development environment. This role is based in Waltham, MA.
Primary Responsibilities Include
- Support the Clinical Study Lead and cross-functional study team across all phases of global clinical trial execution, including feasibility, study planning, start-up, enrollment, maintenance, and closeout activities
- Partner with the Clinical Study Lead to facilitate effective communication across internal study teams, CROs, vendors, and other external partners, helping to proactively identify risks, resolve issues, and keep study activities on track
- Track study metrics, operational milestones, site activation progress, enrollment trends, vendor deliverables, and Sponsor oversight activities; work closely with CROs and vendors to ensure tracking tools are accurate, complete, and current
- Support the review, coordination, and quality control of essential study documents, including informed consent forms, site initiation visit materials, essential regulatory documents, study plans, recruitment materials, manuals, trackers, and other trial-related documents to ensure consistency, accuracy, and compliance
- Assist with the development, routing, distribution, and maintenance of Sponsor study documents and operational materials, such as protocols, protocol amendments, administrative letters, pharmacy manuals, study reference materials, and team communications
- Attend internal study team meetings and external CRO/vendor meetings; prepare and maintain agendas, meeting materials, minutes, decision logs, and action item trackers to support accountability and timely follow-through
- Coordinate logistics and materials for investigator meetings, principal investigator calls, site-facing communications, conferences, vendor meetings, and other study-related forums
- Collect, file, reconcile, and track essential documents for the trial master file (TMF); conduct routine TMF reviews, identify gaps, follow up on missing documentation, and support ongoing inspection readiness activities
- Take initiative to improve Clinical Operations processes by identifying opportunities for standardization, efficiency, quality, and continuous improvement within study teams and across the department
- Maintain and update study tracking tools, dashboards, contact lists, document logs, training records, and other operational resources to support transparency and timely decision-making
- Use sound judgment, intellectual curiosity, and a continuous improvement mindset to identify practical solutions, improve ways of working, and support consistent execution across study teams
- Communicate clearly and professionally with internal and external stakeholders, build effective working relationships, escalate issues appropriately, and follow through on commitments with urgency and attention to quality
Education And Skills Requirements
- Bachelor’s degree in life sciences, healthcare, or a related field preferred; equivalent combination of education and relevant experience may be considered
- 3+ years of relevant hands-on clinical operations or drug development experience, preferably in a Sponsor setting and with exposure to global or multi-site clinical trials
- Working knowledge of clinical trial operations, ICH-GCP guidelines, regulatory requirements, TMF expectations, and inspection readiness principles
- Experience collaborating across multiple functional areas, such as Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Data Management, Biostatistics, Medical Writing, Clinical Supply, Finance, and external vendors
- Proficiency with clinical trial tracking systems, document management tools, Microsoft Office applications, and other systems used to support clinical trial execution and documentation
- Demonstrated ability to work independently, collaborate effectively within cross-functional teams, manage competing priorities, and deliver accurate, high-quality work with strong follow-through
- High level of professionalism, discretion, integrity, accountability, and alignment with Dyne’s values and commitment to patients
- Willingness to travel for job-related activities, including investigator meetings, site visits, conferences, or vendor meetings, if required (expected travel for this position is ~5%)
Compensation
- MA Pay Range: $86,000 - $105,000 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.
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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.