E-3 Visa Clinical Operations Manager Jobs
Clinical Operations Manager roles in the U.S. require a bachelor's degree in a health-related field and a bona fide job offer, making them well-suited for E-3 visa sponsorship. The E-3 has no lottery and no annual cap, so Australian professionals can apply as soon as they secure an offer from a qualifying employer.
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Get Access To All JobsINTRODUCTION
The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical studies conducted in healthy volunteers at Alkermes. This role provides operational leadership for healthy volunteer studies across the clinical development lifecycle, ensuring studies are conducted in compliance with GCP, FDA regulations, ICH guidelines, company SOPs, and project timelines.
The Director will partner closely with Clinical Pharmacology, Translational Medicine, Medical, Biometrics, Regulatory Affairs, Clinical Supply, Quality Assurance, Pharmacovigilance, and CRO partners to ensure successful execution of first-in-human (FIH), SAD, MAD, food effect, relative bioavailability, DDI, QTc, and other early development studies in healthy volunteers.
The successful candidate will be responsible for study budgets, forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous process improvement and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
EQUAL EMPLOYMENT OPPORTUNITY
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
BASIC QUALIFICATIONS
Bachelor's Degree
INTRODUCTION
The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical studies conducted in healthy volunteers at Alkermes. This role provides operational leadership for healthy volunteer studies across the clinical development lifecycle, ensuring studies are conducted in compliance with GCP, FDA regulations, ICH guidelines, company SOPs, and project timelines.
The Director will partner closely with Clinical Pharmacology, Translational Medicine, Medical, Biometrics, Regulatory Affairs, Clinical Supply, Quality Assurance, Pharmacovigilance, and CRO partners to ensure successful execution of first-in-human (FIH), SAD, MAD, food effect, relative bioavailability, DDI, QTc, and other early development studies in healthy volunteers.
The successful candidate will be responsible for study budgets, forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous process improvement and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
Why join Team Alkermes?
Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts’ Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
EQUAL EMPLOYMENT OPPORTUNITY
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
BASIC QUALIFICATIONS
Bachelor's Degree
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Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Clinical Operations Manager
Verify your degree supports specialty occupation
E-3 visa eligibility requires your degree to match the role's field. A clinical operations role typically requires a degree in health sciences, nursing, public health, or life sciences. A business or arts degree alone may not satisfy the specialty occupation requirement.
Target employers with DOL LCA filing history
Search the DOL's Office of Foreign Labor Certification disclosure data to identify healthcare organisations and contract research organisations that have filed LCAs for clinical operations titles. Prior filings signal familiarity with the E-3 sponsorship process.
Negotiate the LCA into your offer conversation
Raise the E-3 sponsorship question before you accept an offer, not after. Confirm the employer will file the LCA with DOL and that your offered wage meets the prevailing wage for your location and SOC code.
Prepare a credentials package before applying
Compile your academic transcripts, any AHPRA registration or equivalent certifications, and a role-specific resume formatted for U.S. clinical operations standards. Having these ready accelerates the employer's LCA filing and your consulate appointment prep.
Use Migrate Mate's E-3 filing service for end-to-end support
Once you have an offer, use Migrate Mate's E-3 filing service to handle your LCA and visa paperwork. This removes the administrative burden from your employer and reduces the risk of errors that delay your consulate appointment.
Understand the E-3 renewal timeline for clinical roles
The E-3 is granted in two-year increments and is renewable indefinitely, but each renewal requires a valid LCA. If your contract or project scope changes materially, your employer needs to file a new LCA before your next renewal application.
E-3 Visa Clinical Operations Manager: Frequently Asked Questions
How do I find Clinical Operations Manager jobs that offer E-3 visa sponsorship?
Migrate Mate is built specifically for Australian professionals searching for U.S. roles with E-3 sponsorship. You can filter by job title and see employers with a track record of sponsoring Australian workers. General job boards don't filter by visa type, so you'll spend significant time screening out roles where sponsorship isn't available.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Clinical Operations Manager role qualify as a specialty occupation for the E-3?
Yes, in most cases. Clinical Operations Manager positions typically require a bachelor's degree or higher in a health-related discipline such as nursing, life sciences, public health, or healthcare administration. The key is demonstrating that the specific role requires that degree, not just that a degree is preferred. If the job description says 'bachelor's preferred,' that wording can create problems at the consulate.
How does the E-3 compare to the H-1B for Clinical Operations Manager roles?
The E-3 is substantially more predictable for Australians. There's no annual lottery, no cap, and no April registration window. You can apply as soon as your employer files a certified LCA with DOL, which typically takes around seven business days. The H-1B visa process requires lottery selection in April with a start date no earlier than October 1, adding six or more months of uncertainty before you can start work.
Can I switch employers while working as a Clinical Operations Manager on an E-3?
Yes, but you can't simply transfer your existing E-3. Your new employer must file a fresh LCA with DOL for the new role and location, and you'll need to attend a new consulate interview to receive an updated visa stamp. You can begin working for the new employer once the LCA is certified and you hold a valid E-3 status tied to that offer, though rules around timing and status maintenance apply.