Clinical Operations Lead Jobs in USA with Visa Sponsorship
Clinical Operations Leads manage clinical trial execution and site oversight, roles that qualify as specialty occupations under H-1B visa and E-3 visas. Employers in biotech, pharma, and CROs regularly sponsor this title. A life sciences or health-related degree is typically required to support the petition. For detailed occupation requirements, see the O*NET profile.
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About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).
Responsibilities
- Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team
- For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
- Interacts with and influences cross-functional team members to achieve program and study objectives
- Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
- Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
- Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
- Participates in CDSO and cross-functional innovation and process improvement initiatives
- Contributes to study execution “lessons learned” across functions
Qualifications
- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired
- Must have at least 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and/or applicable work experience)
- Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
- Demonstrated effective leadership skills
- Demonstrated ability to influence others without direct authority
- Demonstrated effective communication skills
- Demonstrated effective analytical skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
AbbVie Clinical Data Strategy and Operations is the best-in-class team within its cross-industry peer group and is responsible for bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and innovation. This role is key to ensuring successful delivery against the program- and study-level accountabilities assigned to Clinical Data Strategy and Operations (CDSO).
Responsibilities
- Aligns CDSO study teams with program- and study-level strategies. For assigned studies, leads the CDSO Study Team and represents CDSO as a member of the cross-functional study team
- For assigned studies, acts as single point of contact and accountable operational lead from CDSO. Coordinates associated CDSO study teams to meet operational objectives. Engages and connects global functional and cross-functional teams
- Interacts with and influences cross-functional team members to achieve program and study objectives
- Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
- Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
- Participates in oversight of vendors and provides feedback related to study operations, issues, and trends in performance
- Responsible for coaching and mentoring Data Science Associates. May include indirect supervision of work for contract resources
- Participates in CDSO and cross-functional innovation and process improvement initiatives
- Contributes to study execution “lessons learned” across functions
Qualifications
- Bachelor’s degree in business, management information systems, computer science, life sciences or equivalent. Master’s preferred. PMP Certification or Lean Six Sigma Green Belt desired
- Must have at least 3+ years of pharma / clinical research / data management / health care experience or 5+ years of project management experience (and/or applicable work experience)
- Strong understanding of clinical trial process and clinical technology. Experience in managing a clinical trial from initiation through to completion is preferred
- Demonstrated effective leadership skills
- Demonstrated ability to influence others without direct authority
- Demonstrated effective communication skills
- Demonstrated effective analytical skills
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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Get Access To All JobsTips for Finding Clinical Operations Lead Jobs
Target CROs and biotech sponsors first
Contract research organizations and mid-size biotech companies file more Clinical Operations Lead H-1B petitions than most employers. They have established immigration infrastructure and are more experienced navigating the sponsorship process than smaller clinical sites.
Confirm your degree supports the specialty occupation
USCIS requires a direct nexus between your degree field and the role. Life sciences, nursing, public health, or biomedical engineering degrees generally satisfy this. A general business degree alone is unlikely to hold up without substantial supporting documentation.
Understand what the LCA certifies
Before your visa petition is filed, your employer submits a Labor Condition Application to the Department of Labor certifying the prevailing wage for your location and role. This step must be completed before USCIS can adjudicate your H-1B petition.
Ask about premium processing upfront
Clinical trial timelines are often fixed and delay-sensitive. Premium processing reduces USCIS adjudication to 15 business days. Raise this with your employer before accepting an offer so timelines align with your start date and any protocol obligations.
Australians should explore the E-3 pathway
The E-3 visa is available exclusively to Australian citizens and has no lottery. Clinical Operations Lead qualifies as a specialty occupation under E-3. Applications are processed at Australian consulates, and approval often comes within weeks of the interview.
Document your protocol and site management experience
Strong sponsorship cases for this role include evidence of ICH-GCP compliance work, IRB interactions, and clinical site oversight. Concrete documentation of these responsibilities strengthens the specialty occupation argument if USCIS issues a Request for Evidence.
Frequently Asked Questions
Does Clinical Operations Lead qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. USCIS evaluates whether the role normally requires a bachelor's degree or higher in a specific field. Clinical Operations Lead positions that require a life sciences, public health, or clinical research degree and involve protocol management, regulatory compliance, and site oversight generally satisfy the specialty occupation standard. Roles framed too broadly, with no specific degree requirement listed in the job posting, are more likely to receive a Request for Evidence.
What degree do I need to get sponsored as a Clinical Operations Lead?
Most successful H-1B visa and E-3 petitions for this role are supported by degrees in life sciences, nursing, biomedical engineering, public health, or a closely related field. A general healthcare administration degree may work with strong supporting documentation. A degree unrelated to clinical research, such as business or liberal arts, will make the specialty occupation argument significantly harder to sustain.
Which types of employers sponsor Clinical Operations Leads most often?
Contract research organizations, mid-size and large pharmaceutical companies, and biotech firms with active clinical programs are the most active sponsors for this title. Academic medical centers occasionally sponsor as well, particularly for roles managing investigator-initiated trials. You can browse verified sponsoring employers currently hiring for this role on Migrate Mate.
Can I transfer my H-1B to a new employer if I'm already a Clinical Operations Lead?
Yes. H-1B portability allows you to start working for a new employer as soon as they file a transfer petition, without waiting for USCIS approval, as long as your current H-1B was approved and you've maintained valid status. Your new employer must file a new LCA and I-129 petition covering the Clinical Operations Lead role at the new worksite location.
How does the E-3 visa compare to the H-1B for this role?
For Australian citizens, the E-3 is a significantly more predictable path. There's no annual lottery, the 10,500-slot annual allocation has never been fully used, and consular processing in Sydney, Melbourne, or Perth typically takes a few weeks. The specialty occupation and degree requirements are the same as H-1B. Both allow two-year validity periods, but E-3 renewals are processed at the consulate rather than through USCIS.
What is the prevailing wage requirement for sponsored Clinical Operations Lead 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.