US Study Start Up Lead
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences.
Thus we need to parse the posting and decide which sections to include.
Sections we can include:
- About the role: maybe combine Business Introduction and Position Summary? The instructions list example headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We need to map content accordingly.
We have:
Business Introduction: description of GSK ambitions, R&D, culture. Could be "About the role"? Actually "About the role" is more about the job, but we could treat Business Introduction as "About GSK" maybe not needed. However we need to include substantive info; we could include a section "About the role" that contains the Position Summary and maybe Business Introduction? But we must not invent headings not in list? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies we can use those headings; we can also use other headings? Probably we should stick to those. So we need to decide which sections have content.
We have:
- Position Summary: description of Study Start-up Lead responsibilities. That could go under "About the role" or "Responsibilities"? Actually Position Summary is a summary of the role; could be "About the role". Then we have "Key Responsibilities" which is a list of duties; that maps to "Responsibilities".
- "Why You?" includes Basic Qualification and Preferred Qualification. That maps to "Requirements" and "Qualifications"? Possibly Basic Qualification = Requirements, Preferred Qualification = Qualifications.
- Skills: list of skills (Agile Thinking, etc.) maps to "Skills".
- Pay: The US annual base salary range etc. That's pay info. So we include Pay section.
- Benefits: description of benefits (health care, retirement, etc.) maps to Benefits.
- Why GSK? Could be "About the role"? But we already have About the role. Could be separate section maybe "About GSK"? Not in list. Could omit or incorporate into About the role? The instruction says prefer a few substantive sections over many thin ones. So we could combine Business Introduction and Why GSK? into About the role? But we need to preserve all substantive info. We could include a section "About the role" that contains Position Summary and maybe Business Introduction and Why GSK? but that may be too much. However we can also have multiple sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. That's many but each substantive.
We must not include Schedule because not mentioned.
We must not include sections with filler.
Now we need to strip boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. So we need to remove the Equal Opportunity Employer paragraph, the notice to employment businesses, the accommodation line, the US Licensed Healthcare Professional line, etc.
Also remove "Find out more: Our approach to R&D" maybe keep? It's a link but not substantive? Might be considered navigation; better to drop.
Also remove "#GSK-LI" maybe a tag; drop.
Also remove "Please visit GSK US Benefits Summary to learn more..." maybe part of benefits but it's a link; we could keep the benefits description but drop the link instruction? The instruction says preserve ALL substantive information; the link is not substantive? It's a reference; maybe we can keep the sentence but drop the URL? Safer to keep the sentence but maybe drop the URL? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. The link is part of the posting; but it's a navigation/link. Might be considered boilerplate? It's a reference to benefits summary; could be considered part of benefits. I'd keep the sentence but maybe strip the URL? However the instruction says preserve ALL substantive information; the URL is substantive? It's a reference; but it's a link; maybe we can keep it as plain text. It's not navigation boilerplate per se; it's a benefits summary link. I'd keep it.
Also remove "If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process." That's part of pay description; keep.
Now we need to format.
We'll produce something like:
About the role
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. Find out more: Our approach to R&D
Position Summary The Study Start-up Lead 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.
But we might want to separate Business Introduction and Position Summary into separate paragraphs; that's fine.
Next:
Responsibilities
- 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.
- Responsible for efficient coordination of activities and may be responsible for the preparation, collation, review, tracking and filing of all documentation required for study start-up. This may include Informed Consent form review, coordinating translations, preparation of central ethics submissions, delivery of documents to sites for local ethics committee submissions.
- 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.
- Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
- Supporting the site engagement lead (SEL) with site activation timelines
Note: The original had some run-on sentences; we need to keep them as is but split into list items. Ensure we preserve all content.
Now Requirements (Basic Qualification):
Requirements
- Bachelor’s degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
- 3+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
- Experience with ICH-GCP, local regulations, and regulatory processes.
Qualifications (Preferred Qualification):
Qualifications
- 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.
- Experience with reviewing and creating Informed Consents.
- Strong written and verbal communication skills.
Skills:
Skills
- Agile Thinking
- Business Acumen
- Clinical Development
- Clinical Research
- Clinical Sciences
- Clinical Trial Designs
- Communication
- Creativity
- Decision Making
- Fostering Collaboration
- Good Clinical Practice (GCP)
- Influencing Without Authority
- Pharmaceutical Industry
- Project Management
- Time Management
Pay:
Pay
The US annual base salary for new hires in this position ranges from $115,500 to $192,500. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Benefits:
Benefits
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. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
We might also include Why GSK? but we already have About the role covering Business Introduction and Position Summary. Why GSK? is similar to Business Introduction but more about GSK mission. Could be considered redundant; we could omit to avoid thin sections. The instruction says prefer a few substantive sections over many thin ones. So we can omit Why GSK? as it's similar to Business Introduction. However we need to preserve ALL substantive information; if we omit Why GSK? we lose that content. But we could incorporate its content into About the role section. Let's merge Why
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. Output ONLY the HTML fragment — no /, no markdown code fences. Thus we need to parse the posting and decide which sections to include. Sections we can include: - About the role: maybe combine Business Introduction and Position Summary? The instructions list example headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to map content accordingly. We have: Business Introduction: description of GSK ambitions, R&D, culture. Could be "About the role"? Actually "About the role" is more about the job, but we could treat Business Introduction as "About GSK" maybe not needed. However we need to include substantive info; we could include a section "About the role" that contains the Position Summary and maybe Business Introduction? But we must not invent headings not in list? The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). It implies we can use those headings; we can also use other headings? Probably we should stick to those. So we need to decide which sections have content.
We have:
- Position Summary: description of Study Start-up Lead responsibilities. That could go under "About the role" or "Responsibilities"? Actually Position Summary is a summary of the role; could be "About the role". Then we have "Key Responsibilities" which is a list of duties; that maps to "Responsibilities".
- "Why You?" includes Basic Qualification and Preferred Qualification. That maps to "Requirements" and "Qualifications"? Possibly Basic Qualification = Requirements, Preferred Qualification = Qualifications.
- Skills: list of skills (Agile Thinking, etc.) maps to "Skills".
- Pay: The US annual base salary range etc. That's pay info. So we include Pay section.
- Benefits: description of benefits (health care, retirement, etc.) maps to Benefits.
- Why GSK? Could be "About the role"? But we already have About the role. Could be separate section maybe "About GSK"? Not in list. Could omit or incorporate into About the role? The instruction says prefer a few substantive sections over many thin ones. So we could combine Business Introduction and Why GSK? into About the role? But we need to preserve all substantive info. We could include a section "About the role" that contains Position Summary and maybe Business Introduction and Why GSK? but that may be too much. However we can also have multiple sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay. That's many but each substantive.
We must not include Schedule because not mentioned.
We must not include sections with filler.
Now we need to strip boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning, duplicated lines, application instructions. So we need to remove the Equal Opportunity Employer paragraph, the notice to employment businesses, the accommodation line, the US Licensed Healthcare Professional line, etc.
Also remove "Find out more: Our approach to R&D" maybe keep? It's a link but not substantive? Might be considered navigation; better to drop.
Also remove "#GSK-LI" maybe a tag; drop.
Also remove "Please visit GSK US Benefits Summary to learn more..." maybe part of benefits but it's a link; we could keep the benefits description but drop the link instruction? The instruction says preserve ALL substantive information; the link is not substantive? It's a reference; maybe we can keep the sentence but drop the URL? Safer to keep the sentence but maybe drop the URL? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. The link is part of the posting; but it's a navigation/link. Might be considered boilerplate? It's a reference to benefits summary; could be considered part of benefits. I'd keep the sentence but maybe strip the URL? However the instruction says preserve ALL substantive information; the URL is substantive? It's a reference; but it's a link; maybe we can keep it as plain text. It's not navigation boilerplate per se; it's a benefits summary link. I'd keep it.
Also remove "If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process." That's part of pay description; keep.
Now we need to format.
We'll produce something like:
About the role
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. Find out more: Our approach to R&D
Position Summary The Study Start-up Lead 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.
But we might want to separate Business Introduction and Position Summary into separate paragraphs; that's fine. Next:Responsibilities
- 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.
- Responsible for efficient coordination of activities and may be responsible for the preparation, collation, review, tracking and filing of all documentation required for study start-up. This may include Informed Consent form review, coordinating translations, preparation of central ethics submissions, delivery of documents to sites for local ethics committee submissions.
- 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.
- Leverages AI-enabled tools and digital solutions responsibly to improve efficiency, data quality, and decision-making in clinical trial operations.
- Supporting the site engagement lead (SEL) with site activation timelines
Requirements
- Bachelor’s degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area.
- 3+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
- Experience with ICH-GCP, local regulations, and regulatory processes.
Qualifications
- 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.
- Experience with reviewing and creating Informed Consents.
- Strong written and verbal communication skills.
Skills
- Agile Thinking
- Business Acumen
- Clinical Development
- Clinical Research
- Clinical Sciences
- Clinical Trial Designs
- Communication
- Creativity
- Decision Making
- Fostering Collaboration
- Good Clinical Practice (GCP)
- Influencing Without Authority
- Pharmaceutical Industry
- Project Management
- Time Management
Pay
The US annual base salary for new hires in this position ranges from $115,500 to $192,500. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
Benefits:Benefits
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. Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
We might also include Why GSK? but we already have About the role covering Business Introduction and Position Summary. Why GSK? is similar to Business Introduction but more about GSK mission. Could be considered redundant; we could omit to avoid thin sections. The instruction says prefer a few substantive sections over many thin ones. So we can omit Why GSK? as it's similar to Business Introduction. However we need to preserve ALL substantive information; if we omit Why GSK? we lose that content. But we could incorporate its content into About the role section. Let's merge Why