Clinical Operations Lead Jobs for OPT Students
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
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc.
ROLE AND RESPONSIBILITIES
In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
- Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
- Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
- Build and manage strong relationships with trial investigators and stakeholders.
- Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
- Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
BASIC QUALIFICATIONS
- University degree in medicine, science, or equivalent combination of education & experience
- Demonstrated ability to drive the clinical deliverables of a study
- Subject matter expertise in the designated therapeutic area
- Prior monitoring experience is preferred
- Ability to travel up to 20%
PREFERRED QUALIFICATIONS
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
OUR BENEFITS EXAMPLES INCLUDE
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply.
INTRODUCTION
ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc.
ROLE AND RESPONSIBILITIES
In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will collaborate with cross-functional teams, manage site relationships, and provide strategic guidance to drive the successful delivery of clinical trial outcomes.
- Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
- Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
- Build and manage strong relationships with trial investigators and stakeholders.
- Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
- Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
BASIC QUALIFICATIONS
- University degree in medicine, science, or equivalent combination of education & experience
- Demonstrated ability to drive the clinical deliverables of a study
- Subject matter expertise in the designated therapeutic area
- Prior monitoring experience is preferred
- Ability to travel up to 20%
PREFERRED QUALIFICATIONS
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
OUR BENEFITS EXAMPLES INCLUDE
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here to apply.
How to Get Visa 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.
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.
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Get Access To All JobsFrequently 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.
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