OPT Clinical Operations Lead Jobs
Clinical Operations Lead jobs are a strong fit for F-1 OPT students with backgrounds in clinical research, biomedical sciences, or public health. Most roles qualify as STEM-eligible, giving you up to 36 months of work authorization. Employers in pharma, biotech, and CROs regularly sponsor H-1B visas for this role.
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Get Access To All JobsINTRODUCTION
The AI & ML Operations Engineer designs, builds, and maintains the engineering processes and platform capabilities needed to deploy, monitor, govern, and maintain deployed AI/ML solutions at scale. The role converts validated analytical work into reliable production solutions and manages the operational lifecycle of models and related services while meeting enterprise privacy, security, and support standards.
The engineer partners with data scientists, data engineers, central cloud and infrastructure teams, API and Interoperability teams, Cybersecurity, service owners, and relevant engineering teams to deliver maintainable solutions. The role remains hands-on in engineering, testing, deployment, and troubleshooting while using enterprise-managed capabilities for production data movement, integration, and infrastructure. Scientific method validation remains with the Data Scientist and designated reviewers; this position implements the operational controls for deployed solutions.
This role is part of a new AI & Automation engineering team and will directly design, build, deploy, and support production AI applications and services. Work may include agents, retrieval-augmented generation, orchestration, APIs and integrations, automated evaluation and testing frameworks, observability, monitoring, release and rollback processes, and model/application lifecycle management.
Responsibilities
Model deployment and orchestration. Deploy batch and real-time models and related AI services using approved CI/CD, containers, APIs, and workflow patterns. Build and maintain assigned model deployment and runtime components and coordinate dependencies with enterprise platform owners.
Release management. Automate packaging, versioning, testing, promotion, rollback, and recovery for models and services. Implement retraining or recalibration workflows using criteria defined with data scientists and the required validation and release approvals.
ML platform capabilities. Implement, integrate, configure, and operate approved feature stores, model registries, experiment tracking, and related ML lifecycle capabilities with enterprise platform owners. Partner with Cloud & AI Deployment Engineering and central cloud teams on compute, storage, networking, and deployment.
Deployed-model governance. Implement approved lifecycle controls, access restrictions, lineage, audit trails, change records, and release approvals for deployed models. Maintain traceability across data, code, model, and configuration versions.
Monitoring and reliability. Implement logging, alerts, and monitoring for model performance, drift, data quality, latency, availability, and errors. Work with data scientists, service owners, and relevant engineering teams on measures, thresholds, incident response, and service objectives.
Data and API integration. Work with central data-engineering teams on managed data pipelines and with enterprise API and Interoperability teams on real-time and application integrations, including MuleSoft or other approved API capabilities. Coordinate monitoring, recovery checkpoints, restart procedures, security, and support ownership.
Enterprise support and maintainability. Ensure production solutions have documented dependencies, operational procedures, escalation paths, and ongoing ownership before release. Arrange support with the responsible enterprise teams, including 24/7 coverage where required for critical services, rather than relying on an individual project owner.
AI application operations. Operate assigned LLM, retrieval-based, and agent applications using automated quality checks, model/tool tracing, prompt and configuration versioning, and usage/cost monitoring within the common production lifecycle.
Security and engineering standards. Apply enterprise privacy, security, encryption, role-based access, and sensitive-data controls. Follow common infrastructure-as-code, pull-request, and deployment practices with the responsible teams; bring needed tooling or design exceptions through established review processes.
Collaboration and improvement. Help scientists and partner teams move prototypes into supported production solutions. Review code, tests, and documentation, resolve incidents across dependencies, provide constructive technical feedback, and improve reliability, reproducibility, performance, and efficiency.
BASIC QUALIFICATIONS
- B.S./B.A. in Computer Science, Engineering, Information Systems, or a related field, or an equivalent combination of education and relevant experience.
- At least three years of experience in software engineering, DevOps, or MLOps, including work with production systems.
- Proficiency in Python or another modern programming language, such as Java or Go, sufficient to build, test, troubleshoot, and maintain production components.
- Hands-on experience deploying and operating batch and/or real-time machine-learning models in production.
- Experience with CI/CD tools such as GitHub Actions, GitLab CI, Jenkins, or Azure DevOps; source control, code review, automated testing, and controlled releases.
- Hands-on experience with containerization and orchestration technologies using enterprise-approved platforms and tools.
- Experience in cloud and/or hybrid environments such as AWS, Azure, or GCP.
- Working knowledge of SQL and experience with large datasets and data-workflow orchestration; ability to integrate model services with enterprise-managed pipelines and APIs.
- Experience implementing logging, metrics, monitoring, alerts, and operational diagnostics and investigating failures across model, application, data, and infrastructure dependencies.
- Understanding of security best practices, role-based access control, secrets management, and handling sensitive data.
- Ability to independently deliver assigned engineering work, communicate technical tradeoffs, and collaborate with data scientists, clinicians, data/API teams, cloud/DevOps, security, and support functions.
PREFERRED QUALIFICATIONS
- Experience in healthcare, health technology, or another regulated industry handling PHI/PII.
- Familiarity with EHR/EMR integration and healthcare data standards such as HL7/FHIR, ICD, CPT, LOINC, or SNOMED.
- Experience with ML lifecycle tools such as MLflow, Kubeflow, SageMaker, Vertex AI, or Azure ML, including model registries, feature stores, and experiment tracking.
- Experience with ETL/ELT, data warehouse or lakehouse platforms, enterprise API platforms, infrastructure as code, and formal production-support practices.
- Experience monitoring model drift, fairness, and explainability and implementing healthcare AI governance controls.
- Experience operating LLM, retrieval-based, or agent applications, including quality evaluation, tracing, prompt/configuration management, and cost monitoring.
COMPENSATION
- $109,449.60 - $154,523.20 Annual
INTRODUCTION
The AI & ML Operations Engineer designs, builds, and maintains the engineering processes and platform capabilities needed to deploy, monitor, govern, and maintain deployed AI/ML solutions at scale. The role converts validated analytical work into reliable production solutions and manages the operational lifecycle of models and related services while meeting enterprise privacy, security, and support standards.
The engineer partners with data scientists, data engineers, central cloud and infrastructure teams, API and Interoperability teams, Cybersecurity, service owners, and relevant engineering teams to deliver maintainable solutions. The role remains hands-on in engineering, testing, deployment, and troubleshooting while using enterprise-managed capabilities for production data movement, integration, and infrastructure. Scientific method validation remains with the Data Scientist and designated reviewers; this position implements the operational controls for deployed solutions.
This role is part of a new AI & Automation engineering team and will directly design, build, deploy, and support production AI applications and services. Work may include agents, retrieval-augmented generation, orchestration, APIs and integrations, automated evaluation and testing frameworks, observability, monitoring, release and rollback processes, and model/application lifecycle management.
Responsibilities
Model deployment and orchestration. Deploy batch and real-time models and related AI services using approved CI/CD, containers, APIs, and workflow patterns. Build and maintain assigned model deployment and runtime components and coordinate dependencies with enterprise platform owners.
Release management. Automate packaging, versioning, testing, promotion, rollback, and recovery for models and services. Implement retraining or recalibration workflows using criteria defined with data scientists and the required validation and release approvals.
ML platform capabilities. Implement, integrate, configure, and operate approved feature stores, model registries, experiment tracking, and related ML lifecycle capabilities with enterprise platform owners. Partner with Cloud & AI Deployment Engineering and central cloud teams on compute, storage, networking, and deployment.
Deployed-model governance. Implement approved lifecycle controls, access restrictions, lineage, audit trails, change records, and release approvals for deployed models. Maintain traceability across data, code, model, and configuration versions.
Monitoring and reliability. Implement logging, alerts, and monitoring for model performance, drift, data quality, latency, availability, and errors. Work with data scientists, service owners, and relevant engineering teams on measures, thresholds, incident response, and service objectives.
Data and API integration. Work with central data-engineering teams on managed data pipelines and with enterprise API and Interoperability teams on real-time and application integrations, including MuleSoft or other approved API capabilities. Coordinate monitoring, recovery checkpoints, restart procedures, security, and support ownership.
Enterprise support and maintainability. Ensure production solutions have documented dependencies, operational procedures, escalation paths, and ongoing ownership before release. Arrange support with the responsible enterprise teams, including 24/7 coverage where required for critical services, rather than relying on an individual project owner.
AI application operations. Operate assigned LLM, retrieval-based, and agent applications using automated quality checks, model/tool tracing, prompt and configuration versioning, and usage/cost monitoring within the common production lifecycle.
Security and engineering standards. Apply enterprise privacy, security, encryption, role-based access, and sensitive-data controls. Follow common infrastructure-as-code, pull-request, and deployment practices with the responsible teams; bring needed tooling or design exceptions through established review processes.
Collaboration and improvement. Help scientists and partner teams move prototypes into supported production solutions. Review code, tests, and documentation, resolve incidents across dependencies, provide constructive technical feedback, and improve reliability, reproducibility, performance, and efficiency.
BASIC QUALIFICATIONS
- B.S./B.A. in Computer Science, Engineering, Information Systems, or a related field, or an equivalent combination of education and relevant experience.
- At least three years of experience in software engineering, DevOps, or MLOps, including work with production systems.
- Proficiency in Python or another modern programming language, such as Java or Go, sufficient to build, test, troubleshoot, and maintain production components.
- Hands-on experience deploying and operating batch and/or real-time machine-learning models in production.
- Experience with CI/CD tools such as GitHub Actions, GitLab CI, Jenkins, or Azure DevOps; source control, code review, automated testing, and controlled releases.
- Hands-on experience with containerization and orchestration technologies using enterprise-approved platforms and tools.
- Experience in cloud and/or hybrid environments such as AWS, Azure, or GCP.
- Working knowledge of SQL and experience with large datasets and data-workflow orchestration; ability to integrate model services with enterprise-managed pipelines and APIs.
- Experience implementing logging, metrics, monitoring, alerts, and operational diagnostics and investigating failures across model, application, data, and infrastructure dependencies.
- Understanding of security best practices, role-based access control, secrets management, and handling sensitive data.
- Ability to independently deliver assigned engineering work, communicate technical tradeoffs, and collaborate with data scientists, clinicians, data/API teams, cloud/DevOps, security, and support functions.
PREFERRED QUALIFICATIONS
- Experience in healthcare, health technology, or another regulated industry handling PHI/PII.
- Familiarity with EHR/EMR integration and healthcare data standards such as HL7/FHIR, ICD, CPT, LOINC, or SNOMED.
- Experience with ML lifecycle tools such as MLflow, Kubeflow, SageMaker, Vertex AI, or Azure ML, including model registries, feature stores, and experiment tracking.
- Experience with ETL/ELT, data warehouse or lakehouse platforms, enterprise API platforms, infrastructure as code, and formal production-support practices.
- Experience monitoring model drift, fairness, and explainability and implementing healthcare AI governance controls.
- Experience operating LLM, retrieval-based, or agent applications, including quality evaluation, tracing, prompt/configuration management, and cost monitoring.
COMPENSATION
- $109,449.60 - $154,523.20 Annual
See all 980+ OPT Clinical Operations Lead Jobs
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Get Access To All JobsTips for Finding OPT Sponsorship in Clinical Operations Lead
Target CROs and biotech firms with established OPT pipelines
Contract research organizations like ICON, Syneos, and PRA Health Sciences hire clinical operations staff at scale. These employers have established visa sponsorship infrastructure and are far more likely to support OPT and future H-1B transitions than smaller sponsors.
Confirm your degree qualifies for STEM OPT extension
Clinical Operations Lead roles typically fall under STEM CIP codes in biomedical engineering, public health, or biological sciences. Verify your specific degree program is on the STEM OPT designated list before applying to roles requiring a 24-month extension.
Apply before your OPT end date, not after
Sponsorship timelines for H-1B require employers to file by April 1 for October 1 starts. If your OPT expires before October, you need a STEM extension or a cap-exempt employer. Start conversations about sponsorship at the offer stage, not onboarding.
Highlight regulatory and cross-functional experience on your resume
Employers justify H-1B sponsorship by demonstrating specialty occupation status. Emphasize ICH-GCP compliance knowledge, protocol deviation management, and cross-functional team coordination. These signal the specialized expertise that supports a specialty occupation determination from USCIS.
Ask directly about H-1B sponsorship before accepting offers
Many clinical operations employers sponsor visas but do not advertise it publicly. During the offer stage, ask explicitly whether the company has sponsored H-1B visas for this role before and whether your position would qualify. Silence is not a yes.
Use your OPT period to build a track record in trial management
Employers weighing H-1B sponsorship costs want demonstrated ROI. Use your OPT period to take ownership of site activation metrics, sponsor audits, or TMF management. Documented outcomes during OPT make the sponsorship case significantly easier for your employer.
Clinical Operations Lead OPT: Frequently Asked Questions
Do Clinical Operations Lead jobs qualify for STEM OPT extension?
Most Clinical Operations Lead positions qualify for the 24-month STEM OPT extension, provided your degree is in an eligible field such as biomedical sciences, public health, or a related STEM discipline listed on the DHS STEM OPT designated degree program list. Roles in pharma and CRO settings almost always meet the specialty occupation threshold, but you should confirm your specific degree CIP code with your DSO before applying.
Which types of employers are most likely to sponsor OPT students for Clinical Operations Lead roles?
Large contract research organizations, mid-size biotech companies, and pharmaceutical sponsors with active clinical pipelines are the most consistent sponsors. These employers file high volumes of H-1B petitions annually and have legal teams familiar with OPT-to-H-1B transitions. Migrate Mate filters clinical operations roles by sponsorship history so you can prioritize employers already doing this.
Can I work as a Clinical Operations Lead on OPT without a full-time offer from a single employer?
OPT requires that your work be directly related to your degree field, but it does not require a single full-time employer in most cases. However, Clinical Operations Lead roles are almost always full-time positions given their regulatory and oversight responsibilities. Part-time or consulting arrangements are rare at this level and may complicate your OPT reporting obligations with your DSO.
What happens to my OPT status if my employer goes through a merger or acquisition during my authorization period?
If your employer is acquired or merges with another company, your OPT authorization itself does not automatically terminate, but your I-983 training plan and employer of record details must be updated with your DSO promptly. If the acquiring entity is a fundamentally different employer, a new I-983 may be required. Delays in updating these records can create compliance gaps that affect your immigration record.
Is Clinical Operations Lead considered a specialty occupation for H-1B purposes?
Yes, in the large majority of cases. USCIS has consistently recognized clinical operations roles as specialty occupations when the position requires application of clinical research methodology, regulatory compliance frameworks, or biomedical expertise at a level that normally requires a bachelor's degree or higher in a specific field. Your employer's H-1B petition should document the degree requirement for the specific role to support this classification.