Study Start Up Jobs in USA with Visa Sponsorship
Study Start Up roles sit at the intersection of clinical operations and regulatory compliance, making them a strong fit for H-1B visa and O-1 visa sponsorship. Most positions require a life sciences or healthcare degree, and employers in pharma, biotech, and CROs routinely file LCAs for this specialty occupation.
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Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Essential Functions
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
Qualifications
- Bachelor's Degree Life sciences or related field Req
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities
LOCATION
Durham, United States of America
Job Type
Full time
Compensation
- Salary Range: $103,000.00 - $153,000.00
The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Essential Functions
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/expectations for maintenance of clinical study approvals, authorizations and review/negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
Qualifications
- Bachelor's Degree Life sciences or related field Req
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities
LOCATION
Durham, United States of America
Job Type
Full time
Compensation
- Salary Range: $103,000.00 - $153,000.00
The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and wellness and/or other benefits.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law. Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process.
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.
See all 22+ Study Start Up jobs
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Get Access To All JobsTips for Finding Study Start Up Jobs
Confirm your degree aligns with the role
Study Start Up is consistently classified as a specialty occupation requiring a degree in life sciences, nursing, health sciences, or a related field. A general business degree alone is unlikely to satisfy USCIS without substantial relevant coursework or experience.
Target CROs and large pharma companies first
Contract research organizations and large pharmaceutical sponsors have established immigration infrastructure and sponsor Study Start Up roles regularly. They process more LCAs annually than smaller biotechs and are less likely to back out mid-process due to legal uncertainty.
Understand the LCA certification timeline
Your employer must file a Labor Condition Application with the Department of Labor before submitting your H-1B petition. LCA certification typically takes seven to ten business days, so factor this into your start date planning with the hiring team.
Clarify site travel expectations early
Many Study Start Up roles require frequent domestic or international site visits. If your H-1B covers multiple worksites, your employer may need to file amended petitions or maintain multiple LCAs. Raise this with HR before accepting an offer.
Ask about premium processing upfront
H-1B adjudication without premium processing can take several months. For Study Start Up roles with defined clinical trial timelines, ask whether the employer will elect premium processing to ensure you can begin work within the project window.
Use Migrate Mate to find actively sponsoring employers
Not every CRO or pharma company advertises sponsorship willingness in job listings. Migrate Mate filters Study Start Up roles by employers with active sponsorship history, saving you the time of applying to positions that will stall at the immigration step.
Study Start Up jobs are hiring across the US. Find yours.
Find Study Start Up JobsFrequently Asked Questions
Is Study Start Up considered a specialty occupation for H-1B purposes?
Yes, Study Start Up is generally treated as a specialty occupation by USCIS. The role requires applying specialized knowledge in clinical trial initiation, regulatory submissions, and site qualification, typically tied to a degree in life sciences, health sciences, or a related field. USCIS scrutiny increases if the job description allows a broad range of unrelated degrees, so the employer's petition language matters significantly.
Which visa types are most common for Study Start Up roles?
The H-1B is the primary pathway for Study Start Up professionals who are not Australian or Canadian citizens. Australians may qualify for the E-3 visa, which has no lottery and faster processing. Canadian and Mexican nationals in qualifying scientific or technical roles may explore TN status. O-1A is an option for those with documented recognition, such as publications, awards, or speaking engagements in clinical research.
Does my degree field have to match Study Start Up exactly?
Not exactly, but there must be a logical connection between your degree and the role. Degrees in nursing, pharmacy, biology, biochemistry, health sciences, and related clinical fields are regularly accepted. A purely unrelated degree in an unrelated discipline is a risk factor. If your degree is in a tangential area, strong relevant work experience and any certifications, such as CCRA or CCRP, can help strengthen the petition.
How competitive is H-1B sponsorship for this role compared to other clinical jobs?
Study Start Up sits in a favorable position compared to more general clinical operations titles. Because the role is highly specialized and tied to defined regulatory and site activation processes, it tends to fare better in USCIS review than broadly defined coordinator roles. Large CROs and pharmaceutical companies sponsor consistently, and the role rarely faces the same cap-exempt complications as some academic or nonprofit positions. Browse current openings on Migrate Mate to identify which employers are actively filing.
Can I transfer my H-1B to a new Study Start Up employer if I change companies?
Yes, H-1B portability allows you to start working for a new employer as soon as the transfer petition is filed, provided your current H-1B is valid and you have maintained status. Your new employer must file a new LCA and I-129 petition before or on your first day. Study Start Up roles transfer relatively smoothly since the specialty occupation classification is consistent across most CRO and pharma employers.
What is the prevailing wage requirement for sponsored Study Start Up 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.
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