H-1B Visa Study Start Up Jobs
Study Start Up roles sit at the intersection of clinical research coordination and regulatory compliance, two areas where H-1B visa specialty occupation requirements are consistently met. Employers in this space regularly file LCAs and sponsor H-1B transfers, making it a viable target for skilled professionals seeking long-term U.S. work authorization.
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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 H-1B Visa Study Start Up Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Study Start Up Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Study Start Up
Map your degree to SOC codes
Study Start Up work typically maps to Clinical Research Coordinator or Regulatory Affairs Specialist SOC codes. Pull the O*NET profile for each to confirm the listed degree requirements align with your credentials before targeting employers.
Prioritize employers with active LCA filings
Contract research organizations and academic medical centers file LCAs regularly for Study Start Up roles. Use the OFLC Wage Search to confirm an employer has filed in your target occupation and geography before applying.
Search verified H-1B sponsors on Migrate Mate
Migrate Mate filters Study Start Up jobs by employers with confirmed H-1B filing history, so you skip companies that won't sponsor. Narrow by location and role type to build a shortlist before outreach.
Get your credentials evaluated early
If your clinical research or life sciences degree is from outside the U.S., get a credential evaluation completed before interviews. Employers and USCIS both need to confirm your degree meets specialty occupation standards for this role.
Clarify LCA timing during the offer stage
Ask the hiring manager whether the employer files the LCA in-house or through outside counsel. In-house filers often move faster, which matters if you're on OPT cap-gap or need to hit the October 1 H-1B start date.
Understand the 60-day portability window
If you're transferring an existing H-1B to a new Study Start Up employer, your new employer can file a concurrent I-129 so you're authorized to start without waiting for approval. Confirm this option before giving notice at your current role.
H-1B Visa Study Start Up: Frequently Asked Questions
Does a Study Start Up role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. Study Start Up roles require applied knowledge of regulatory submissions, protocol feasibility, and site activation processes that typically demand a bachelor's degree or higher in clinical research, life sciences, or a related field. USCIS evaluates specialty occupation on a case-by-case basis, so your employer's petition needs to document that the specific position requires that degree-level expertise.
Which types of employers commonly sponsor H-1B visas for Study Start Up positions?
Contract research organizations, academic medical centers, hospital networks, and mid-size biotech companies are the most consistent H-1B sponsors for Study Start Up roles. Site management organizations that manage multi-site trials also file regularly. You can find employers with verified H-1B filing history for this role type on Migrate Mate, filtered by location and industry.
Can I transfer my H-1B to a new employer for a Study Start Up role mid-year?
Yes. H-1B portability under AC21 lets you start working for a new employer as soon as the transfer petition is filed with USCIS, without waiting for approval, as long as your current H-1B was approved and you've been in valid status. Your new employer files an I-129 with a certified LCA covering your Study Start Up title and work location.
What documentation strengthens an H-1B petition for a Study Start Up role?
The petition needs an LCA certified by DOL at the correct prevailing wage level, a detailed job description tying the role to specialty occupation criteria, and evidence that the position requires a specific degree field. Clinical research certifications, protocol experience letters from previous employers, and IRB or regulatory training records all help establish that the role isn't a generalist position.
How does the H-1B cap lottery affect Study Start Up job seekers?
Most Study Start Up roles at for-profit employers are subject to the annual H-1B cap, which means your petition enters the lottery held each spring for an October 1 start date. Roles at nonprofit research institutions or universities may qualify for cap-exempt status, letting employers file year-round. USCIS publishes cap-exempt employer categories, and confirming your target employer's status before accepting an offer saves significant planning effort.