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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Get Access To All JobsBusiness Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Position Summary
The Associate Director, Study Start-up is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. This includes, but it’s not limited to the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPRM for core and CRO-managed countries. The role is the accountable person for the study start up metrics (these metrics can be shared with other directors/manager depending on local leadership roles, where appropriate).
This position works directly with Clinical Operations Head, LDL Managers, SEL/LDL, STEP team, CRO FSP (Functional Service Provider) Managers and/or BDL where appropriate, in setting priorities and expectations for Study Start-Up.
The role is supporting the life cycle of the studies and improve processes across functions.
This position may manage Study Start Up Leads (SSUL), Clinical Operations Specialists (COS) and other functions involved in study start up activities, depending on countries.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Accountable to ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start up timelines according to set metrics, budget and quality target working according to country/regional (where appropriate) regulations, GSK SOPs and ICH GCP.
- Support operations between the central GSK study team, global SSU team and within-country study team for study start up activities.
- Ensures that critical study timelines related to study start up activities within-country are accurately forecasted.
- Accountable for maintaining internal tracking for study site status from initial site contact through site initiation. Maintains clear internal team communication and documentation to ensure site activation timelines are met.
- Accountable for the delivery of country feasibility, site selection, recruitment planning, site training and/or regulatory package completion.
- Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise. Responsible for identifying and sharing best practices.
- Connects with local internal and external experts to keep up to date with changes in site start-up requirements. Learns from past site activations and performance and continually improves future activities.
- Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model.
- Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
- Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the improvement of clinical research activities in the national environment.
- Accountable to lead Study Start Up Leads and/or Local Clinical Operations Specialists to ensure timely start-up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to country/regional regulations, GSK SOPs and GCP.
- Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance.
- Responsible for resource management and allocation to maintain business performance and a sustainable workload.
Why You?
Working model
This role is remote within the United States with a hybrid expectation for in-person engagement. Regular domestic travel will be required to build relationships and support study delivery.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
- 5+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
- Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
- Experience managing study start-up activities across multiple sites in the US.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree such as Master’s, PharmD, or PhD.
- Demonstrated leadership skills and experience working in matrix teams.
- Experience in budget control and monitoring of performance indicators.
- Analytical skills and a results-oriented mindset, with a focus on operational efficiency and quality.
- Proven track record of reducing study start-up timelines or improving activation metrics.
- Strong stakeholder engagement, negotiation and influencing skills.
- Experience leading cross-functional projects or process improvement initiatives.
Skills
Agile Thinking, Business Acumen, Clinical Development, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, People Management, Pharmaceutical Industry, Project Management, Time Management.
The US annual base salary for new hires in this position ranges from $129,750 to $216,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Position Summary
The Associate Director, Study Start-up is responsible for providing leadership in the execution of operational strategy and management of start-up activities for all clinical trials, across all therapy areas. This includes, but it’s not limited to the overall management and oversight of the following processes: preparation and submission of CTA for EC and CA, site contracts and TPRM for core and CRO-managed countries. The role is the accountable person for the study start up metrics (these metrics can be shared with other directors/manager depending on local leadership roles, where appropriate).
This position works directly with Clinical Operations Head, LDL Managers, SEL/LDL, STEP team, CRO FSP (Functional Service Provider) Managers and/or BDL where appropriate, in setting priorities and expectations for Study Start-Up.
The role is supporting the life cycle of the studies and improve processes across functions.
This position may manage Study Start Up Leads (SSUL), Clinical Operations Specialists (COS) and other functions involved in study start up activities, depending on countries.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Accountable to ensure timely start-up of all clinical studies across multiple therapeutic areas to agreed start up timelines according to set metrics, budget and quality target working according to country/regional (where appropriate) regulations, GSK SOPs and ICH GCP.
- Support operations between the central GSK study team, global SSU team and within-country study team for study start up activities.
- Ensures that critical study timelines related to study start up activities within-country are accurately forecasted.
- Accountable for maintaining internal tracking for study site status from initial site contact through site initiation. Maintains clear internal team communication and documentation to ensure site activation timelines are met.
- Accountable for the delivery of country feasibility, site selection, recruitment planning, site training and/or regulatory package completion.
- Actively works with stakeholders to simplify/optimize processes as it relates to their area of expertise. Responsible for identifying and sharing best practices.
- Connects with local internal and external experts to keep up to date with changes in site start-up requirements. Learns from past site activations and performance and continually improves future activities.
- Consulted for the LOC CRO’s oversight (operational aspects) when studies are delivered through the FSO (Fully Study Outsourced) Model.
- Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
- Represent GSK in key events (i.e Forum, Symposium, Trade Association, etc) and discussion related to the improvement of clinical research activities in the national environment.
- Accountable to lead Study Start Up Leads and/or Local Clinical Operations Specialists to ensure timely start-up, operational management, completion and delivery of all clinical studies across multiple therapeutic areas to agreed start up timelines according to UQ (Upper Quartile), budget and quality target working according to country/regional regulations, GSK SOPs and GCP.
- Accountable for line and performance management of Team Members: conduct regular 1:1 meeting, develop staff competencies and identify skill gaps. Arranges appropriate training to ensure they have the skills and knowledge required. Utilizes coaching and mentoring strategy to enhance individual and overall team performance.
- Responsible for resource management and allocation to maintain business performance and a sustainable workload.
Why You?
Working model
This role is remote within the United States with a hybrid expectation for in-person engagement. Regular domestic travel will be required to build relationships and support study delivery.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
- University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
- 5+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
- Solid knowledge of ICH-GCP, local regulations, and regulatory processes.
- Experience managing study start-up activities across multiple sites in the US.
Preferred Qualification
If you have the following characteristics, it would be a plus:
- Advanced degree such as Master’s, PharmD, or PhD.
- Demonstrated leadership skills and experience working in matrix teams.
- Experience in budget control and monitoring of performance indicators.
- Analytical skills and a results-oriented mindset, with a focus on operational efficiency and quality.
- Proven track record of reducing study start-up timelines or improving activation metrics.
- Strong stakeholder engagement, negotiation and influencing skills.
- Experience leading cross-functional projects or process improvement initiatives.
Skills
Agile Thinking, Business Acumen, Clinical Development, Clinical Trial Designs, Communication, Creativity, Decision Making, Fostering Collaboration, Good Clinical Practice (GCP), Influencing Without Authority, People Management, Pharmaceutical Industry, Project Management, Time Management.
The US annual base salary for new hires in this position ranges from $129,750 to $216,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/
See all 32+ Study Start Up Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Study Start Up roles.
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.
Frequently 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 visa 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 visa 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.