H-1B Visa Clinical Trial Manager Jobs
Clinical Trial Manager roles qualify as H-1B specialty occupations under USCIS guidelines, typically requiring a bachelor's degree or higher in life sciences, nursing, or a related field. Sponsors file your LCA with DOL before petitioning USCIS, and many CROs, biotech firms, and academic medical centers have active H-1B filing histories.
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Get Access To All JobsSUMMARY
The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or in-house, depending on prior experience. This position will report to a Clinical Operations Manager. Bay Area staff will operate in a hybrid or office based model aligned with Arcus expectations.
Responsibilities
- Day-to-day management of assigned operational aspects of low to medium complex clinical trials, including but not limited to vendor/laboratory management, oversight of clinical sites, etc.
- Obtains and reviews all required essential documents necessary for study/site initiation
- Maintains/files accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
- Manages and tracks patient enrollment, site performance and monitoring metrics
- Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies
- Supports the development and review of clinical study plans, presentations or study-related documents
- Support in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems
- Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed
- Works closely with data management lead to perform data cleaning activities with cross-functional team
- May lead and coordinate protocol deviation review and documentation
- Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
- May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as required
- Reviews monitoring trip reports and track resolution of all action items
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
- Assists with providing oversight of CROs and vendors
- Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues
- Assists with set-up and review of clinical TMF
- Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
- Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.
- Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
- Recommend and implement innovative ideas to increase efficiency and quality of program management activities
- Contributes to process and departmental and cross-functional improvement activities
QUALIFICATIONS
- Bachelor’s degree, preferably in a scientific field
- 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology
- Demonstrates core understanding of clinical trial related terminology and activities
- Thorough understanding of ICH GCP guidelines and Code of Federation Regulations
- Understanding of clinical trial processes from study start-up through study closure
- Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Excellent planning and organization skills
- Self-motivated, assertive, and able to function independently and as part of a team
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
- Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
- Ability and willingness to travel 10-20% (domestic and international)
#LI-Remote
#LI-JS1
SUMMARY
The Clinical Trial Manager (CTM) will provide clinical study support to the Clinical Program Manager/Study Management Team Lead (SMTL) for one or more clinical studies, ensuring efficient delivery of clinical trials in a matrix environment. Key accountabilities include assuring successful conduct of clinical studies consistent with applicable regulations, guidelines and procedures, as well as supporting clinical project timelines, contracts, budgets, vendor management, invoicing, accruals, oversight monitoring visits, meeting milestones and deliverables, and internal/external communications. This position is remote or in-house, depending on prior experience. This position will report to a Clinical Operations Manager. Bay Area staff will operate in a hybrid or office based model aligned with Arcus expectations.
Responsibilities
- Day-to-day management of assigned operational aspects of low to medium complex clinical trials, including but not limited to vendor/laboratory management, oversight of clinical sites, etc.
- Obtains and reviews all required essential documents necessary for study/site initiation
- Maintains/files accurate and timely sponsor/site correspondence and communication. Prepares and presents project progress reports
- Manages and tracks patient enrollment, site performance and monitoring metrics
- Performs tasks in accordance with ICH GCP, regulations, the protocol, and company SOPs/Policies
- Supports the development and review of clinical study plans, presentations or study-related documents
- Support in the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT on related systems
- Assists with set-up of central labs and study vendors as required, including liaising with Clinical Program Manager and CRO to ensure site training and timely initiation of clinical study sites
- Performs in-house review of clinical data listings for completeness and accuracy and escalate issues to the Clinical Program Manager, as needed
- Works closely with data management lead to perform data cleaning activities with cross-functional team
- May lead and coordinate protocol deviation review and documentation
- Manage clinical monitoring activities and the overall site management ensuring compliance with Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
- May perform accompanied site visits with CRO Site Monitors to ensure correct study procedures according to SOPs and protocol procedures, review of routine regulatory documents/files in compliance with protocol, regulatory requirements, site and CRO SOPs, and study plans, as required
- Reviews monitoring trip reports and track resolution of all action items
- Participates in the selection, training, and evaluation of study personnel (vendor, CRO, internal)
- Assists with providing oversight of CROs and vendors
- Coordinates with CRO and SMTL in clinical site oversight, data entry timeliness, assists with resolving site issues
- Assists with set-up and review of clinical TMF
- Organizes and manages internal team meetings, investigator meetings, and other trial specific meetings, as requested
- Contributes to development and review of clinical trial documents such as clinical protocol, informed consent form(s), patient facing materials, etc.
- Provides support in the development and management of vendor scope of work (SOW) per contract, quality, budget, and detailed timelines including investigator and vendor payments, as applicable
- Recommend and implement innovative ideas to increase efficiency and quality of program management activities
- Contributes to process and departmental and cross-functional improvement activities
QUALIFICATIONS
- Bachelor’s degree, preferably in a scientific field
- 5+ years of related industry experience in the pharmaceutical industry or equivalent, plus 2+ years of trial management experience, preferably in oncology
- Demonstrates core understanding of clinical trial related terminology and activities
- Thorough understanding of ICH GCP guidelines and Code of Federation Regulations
- Understanding of clinical trial processes from study start-up through study closure
- Ability to establish priorities, sense of urgency and collaborate (interpersonal, relationship management) with the study team, cross functional team members and external partners/vendors
- Excellent planning and organization skills
- Self-motivated, assertive, and able to function independently and as part of a team
- Strong interpersonal and negotiation skills as well as strong verbal and written communication (including presentation of materials to internal teams and external partners)
- Excellent IT Microsoft skills and experience using clinical trial management web-based systems (i.e. EDC, IRT, CTMS, eTMF, etc.)
- Ability and willingness to travel 10-20% (domestic and international)
#LI-Remote
#LI-JS1
See all 288+ Clinical Trial Manager jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Clinical Trial Manager roles.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Clinical Trial Manager
Verify your degree meets specialty occupation
USCIS requires your degree field to directly relate to clinical trial management. A nursing, biology, or public health degree typically qualifies; a general business degree usually doesn't. Get a credential evaluation if your degree is from outside the U.S.
Target CROs with consistent LCA filing histories
Contract Research Organizations file LCAs for Clinical Trial Manager roles far more consistently than most employers. Use the OFLC Wage Search to confirm a CRO has filed for your specific occupation code before investing time in their application process.
Check the O*NET profile before your interview
The O*NET occupation profile for Clinical Trial Managers defines the core tasks USCIS uses to evaluate specialty occupation status. Align your resume and interview answers to those defined duties so your employer's H-1B petition matches your actual role description.
Find H-1B sponsors on Migrate Mate
Search Clinical Trial Manager roles on Migrate Mate to see which employers have verified H-1B filing histories in this occupation. Filter by employer type to prioritize CROs, biotech sponsors, and academic medical centers actively petitioning for this role.
Negotiate LCA filing before your start date
Your employer must file a certified LCA with DOL before submitting your H-1B petition to USCIS. Confirm your offer letter specifies a start date that gives at least 60 days of buffer for LCA certification and I-129 preparation.
Clarify multi-site work in your petition
Clinical Trial Managers often work across multiple trial sites, which requires separate LCA filings for each worksite location. Confirm your employer's immigration counsel accounts for all trial sites in the petition; missing a location is a common RFE trigger.
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Find Clinical Trial Manager JobsClinical Trial Manager H-1B Visa: Frequently Asked Questions
Does a Clinical Trial Manager role qualify as an H-1B specialty occupation?
Yes. Clinical Trial Manager positions qualify as H-1B specialty occupations because they typically require at least a bachelor's degree in a directly related field such as life sciences, nursing, or public health. USCIS evaluates whether the specific duties listed in your employer's petition match that degree requirement, so your job description needs to reflect the complexity and specialization of the role.
Which types of employers sponsor H-1B visas for Clinical Trial Managers?
Contract Research Organizations, mid-size biotech companies, academic medical centers, and large pharmaceutical firms are the most consistent H-1B sponsors for this role. Smaller site management organizations occasionally sponsor but less reliably. You can search verified H-1B filing histories for Clinical Trial Manager positions on Migrate Mate to identify which employers are actively petitioning.
Can I work across multiple clinical trial sites on a single H-1B?
Only if your employer files a separate LCA for each worksite where you'll spend time. USCIS and DOL require LCA coverage for every physical location where H-1B work is performed. If your role involves rotating across sites in different metropolitan statistical areas, your employer's petition must include certified LCAs for each. This is a frequent oversight that leads to Requests for Evidence.
How does the H-1B prevailing wage requirement affect Clinical Trial Manager hiring?
Your employer must pay you at or above the prevailing wage for Clinical Trial Managers in your worksite's geographic area, as determined by DOL wage level data. You can look up the applicable wage using the OFLC Wage Search by entering the relevant occupation code and location. Employers who underpay relative to the prevailing wage risk LCA denial or audit.
What happens to my H-1B status if my employer transfers me between clinical programs?
An internal transfer to a materially different role or title may require an amended H-1B petition filed with USCIS before the change takes effect. Moving from a coordinator-level function to a senior managerial one, or shifting from oncology trials to a different therapeutic area with distinct duties, can qualify as a material change. Confirm with your employer's immigration counsel before any role adjustment is finalized.
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