Clinical Trial Manager Jobs in USA with Visa Sponsorship
Clinical Trial Managers are in high demand across U.S. biotech, pharma, and CROs, and most employers in this space have established H-1B visa and E-3 visa sponsorship pipelines. A master's degree or bachelor's in life sciences with several years of CRA experience is the typical qualifying profile. For detailed occupation requirements, see the O*NET profile.
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Get Access To All JobsINTRODUCTION
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Position Summary
The Senior Clinical Trial Manager (SCTM) is responsible for the day-to-day operational management and execution of one or more outsourced studies, from protocol concept through clinical study report, under the oversight of Clinical Operations leadership. The SCTM combines scientific understanding of the protocol with operational command of delivery, ensuring CRO and vendor partners execute on time, on budget and inspection-ready. Studies may sit in Clinical Development or Medical Affairs.
DUTIES AND RESPONSIBILITIES:
- Serve as the day-to-day operational lead for assigned cross-functional study teams (Clinical Sciences/Operations, Medical, Biometrics, Regulatory, CMC/supply, Safety, vendors) and the CRO study team for assigned studies and escalating significant matters to Clinical Operations leadership.
- Develop and maintain the integrated study plan, timelines and milestones; identify risks early and implement or escalate mitigation actions as appropriate.
- Manage start-up activities: country and site selection input, feasibility, essential document strategy, IRB/EC and regulatory submissions with CRO.
- Track enrollment and retention against plan; lead recruitment contingency actions with the CRO and sites.
- Contribute to protocol, amendment, ICF, CRF, monitoring plan and data management plan development so operational design supports the scientific question.
- Perform ongoing clinical data review with Medical, Data Mgmt/Stats; triage protocol deviations and data trends.
- Support investigator meetings, site training and scientific Q&A; prepare study content for publications and CSRs.
- Serve as day-to-day sponsor operational contact for the CRO and specialty vendors (e.g. central lab, IRT, eCOA, imaging, data management).
- Monitor vendor performance against contract, KPIs and quality expectations; escalate issues with documented evidence.
- Review and approve vendor plans, monitoring visit reports (risk-based sample) and deliverables per the oversight plan.
- Track assigned study budgets, accruals and forecast; review and reconcile CRO and vendor invoices against milestones and pass-throughs. Escalate material variances to Clinical Operations leadership.
- Identify out-of-scope work early and partner with the Director on change orders.
- Apply ICH E6(R3) risk-based quality management: critical-to-quality factors, risk review and quality tolerance limits.
- Maintain TMF completeness and quality in partnership with the CRO; keep the study inspection-ready at all times.
- Support audits and inspections; manage CAPAs arising from assigned studies. Escalate significant findings to Clinical Operations leadership.
- For Phase 3b/4, registry, real-world and chart review studies, the SCTM also coordinates with Medical Affairs on study rationale, scientific review committee submissions and publication timelines, and applies a proportionate oversight model suited to study risk.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in life sciences, nursing, pharmacy or related field; advanced degree preferred.
- 7+ years of clinical research experience, including 5+ years managing studies at a sponsor or CRO.
- Demonstrated oversight of outsourced studies and CRO partners.
- Working knowledge of ICH E6(R3), FDA and EU CTR requirements, and TMF standards.
- Experience in Immunology, Oncology, Hematology preferred; Phase 2-4 and post-approval study experience valued.
- Proficiency with CTMS and eTMF (e.g. Veeva Vault) and study budget tracking.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
INTRODUCTION
Precigen (Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need. Precigen is dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.
Position Summary
The Senior Clinical Trial Manager (SCTM) is responsible for the day-to-day operational management and execution of one or more outsourced studies, from protocol concept through clinical study report, under the oversight of Clinical Operations leadership. The SCTM combines scientific understanding of the protocol with operational command of delivery, ensuring CRO and vendor partners execute on time, on budget and inspection-ready. Studies may sit in Clinical Development or Medical Affairs.
DUTIES AND RESPONSIBILITIES:
- Serve as the day-to-day operational lead for assigned cross-functional study teams (Clinical Sciences/Operations, Medical, Biometrics, Regulatory, CMC/supply, Safety, vendors) and the CRO study team for assigned studies and escalating significant matters to Clinical Operations leadership.
- Develop and maintain the integrated study plan, timelines and milestones; identify risks early and implement or escalate mitigation actions as appropriate.
- Manage start-up activities: country and site selection input, feasibility, essential document strategy, IRB/EC and regulatory submissions with CRO.
- Track enrollment and retention against plan; lead recruitment contingency actions with the CRO and sites.
- Contribute to protocol, amendment, ICF, CRF, monitoring plan and data management plan development so operational design supports the scientific question.
- Perform ongoing clinical data review with Medical, Data Mgmt/Stats; triage protocol deviations and data trends.
- Support investigator meetings, site training and scientific Q&A; prepare study content for publications and CSRs.
- Serve as day-to-day sponsor operational contact for the CRO and specialty vendors (e.g. central lab, IRT, eCOA, imaging, data management).
- Monitor vendor performance against contract, KPIs and quality expectations; escalate issues with documented evidence.
- Review and approve vendor plans, monitoring visit reports (risk-based sample) and deliverables per the oversight plan.
- Track assigned study budgets, accruals and forecast; review and reconcile CRO and vendor invoices against milestones and pass-throughs. Escalate material variances to Clinical Operations leadership.
- Identify out-of-scope work early and partner with the Director on change orders.
- Apply ICH E6(R3) risk-based quality management: critical-to-quality factors, risk review and quality tolerance limits.
- Maintain TMF completeness and quality in partnership with the CRO; keep the study inspection-ready at all times.
- Support audits and inspections; manage CAPAs arising from assigned studies. Escalate significant findings to Clinical Operations leadership.
- For Phase 3b/4, registry, real-world and chart review studies, the SCTM also coordinates with Medical Affairs on study rationale, scientific review committee submissions and publication timelines, and applies a proportionate oversight model suited to study risk.
- Other duties as assigned.
EDUCATION AND EXPERIENCE:
- Bachelor's degree in life sciences, nursing, pharmacy or related field; advanced degree preferred.
- 7+ years of clinical research experience, including 5+ years managing studies at a sponsor or CRO.
- Demonstrated oversight of outsourced studies and CRO partners.
- Working knowledge of ICH E6(R3), FDA and EU CTR requirements, and TMF standards.
- Experience in Immunology, Oncology, Hematology preferred; Phase 2-4 and post-approval study experience valued.
- Proficiency with CTMS and eTMF (e.g. Veeva Vault) and study budget tracking.
DESIRED KEY COMPETENCIES:
- Self-organizer, highly motivated, and keen attention to detail.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- Ability to understand and execute the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Exhibits an open mindset when approaching challenges and conflict.
- Ability to think and adapt to a rapidly changing environment and demands.
- Strong time management and organizational skills.
- Ability to manage multiple projects in a fast-paced environment.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Clinical Trial Manager
Target CROs and large pharma first
Contract research organizations like ICON, Syneos, and Medpace file H-1B petitions at scale every year. Their established legal infrastructure makes sponsorship smoother and faster than pursuing smaller biotech startups with no prior sponsorship history.
Confirm your degree field matches the role
USCIS treats CTM roles as specialty occupations requiring a degree in life sciences, nursing, pharmacy, or a closely related field. A general business or unrelated science degree may not satisfy the specialty occupation requirement without additional documentation.
Get your GCP and ICH certifications current
Good Clinical Practice certification is a baseline expectation for CTM roles in the U.S. Having current, verifiable GCP training signals readiness to start quickly and reduces employer hesitation around the time and cost of sponsorship.
Raise sponsorship after demonstrating therapeutic fit
Employers weigh therapeutic area experience heavily for CTM roles. Leading with your oncology, neurology, or rare disease background before the sponsorship conversation shifts the focus to your value, making cost and visa complexity feel secondary.
Understand the LCA wage requirement upfront
Every H-1B petition requires a Labor Condition Application certifying the offered wage meets the prevailing wage for the role and location. Knowing this process reassures employers that sponsorship has clear legal guardrails and is not an open-ended financial commitment.
Use Migrate Mate to find sponsorship-open roles
Most job postings don't advertise visa sponsorship directly. Migrate Mate filters specifically for employers willing to sponsor, so you're not wasting applications on companies that won't engage with international candidates at the offer stage.
Frequently Asked Questions
Do Clinical Trial Manager roles typically qualify for H-1B sponsorship?
Yes. CTM positions qualify as specialty occupations under the H-1B visa because they require at minimum a bachelor's degree in a specific field such as life sciences, pharmacy, or nursing. USCIS has consistently approved H-1B petitions for this title, particularly when the job description includes protocol oversight, site management, and clinical data responsibilities tied to a relevant degree.
What degree do I need for an employer to sponsor my visa as a CTM?
A bachelor's degree in life sciences, nursing, pharmacy, public health, or a closely related field is the baseline. Many employers and USCIS adjudicators look for degrees in biology, biochemistry, or clinical research specifically. A degree in a loosely related field may require a credential evaluation or supporting documentation to establish the degree-to-job connection required for specialty occupation approval.
Are Australian Clinical Trial Managers eligible for the E-3 visa?
Yes. Australian citizens with a qualifying degree and a U.S. employer willing to file a Labor Condition Application can apply for the E-3 visa, which has no annual lottery. CTM roles meet the specialty occupation standard the E-3 requires. The E-3 is issued in two-year increments and can be renewed indefinitely, making it a stable long-term option for Australians working in clinical operations.
How competitive is it to get H-1B sponsorship as a Clinical Trial Manager?
CTMs with three or more years of CRA or site management experience and a relevant life sciences degree are competitive candidates for sponsorship. CROs and mid-to-large pharma companies sponsor H-1B workers regularly for this role. The main constraint is the annual H-1B lottery, not employer willingness. Australians can sidestep the lottery entirely with the E-3 visa. Browse open roles on Migrate Mate to see which employers are actively sponsoring.
Can I transfer my H-1B to a new CTM employer mid-study?
Yes. H-1B portability allows you to change employers once your new employer files a transfer petition, even before it's approved, as long as your current H-1B was properly approved and you've maintained valid status. For CTMs mid-trial, timing matters since your name may be on regulatory documents. Coordinate with both employers and an immigration attorney before making the move.
What is the prevailing wage requirement for sponsored 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.