US Study Start Up Lead

GSK; Philadelphia (Philadelphia County); On-site; USD 116,000 - 193,000; Full time

Benefits offered by this job

Health insurance

Retirement benefits

Paid holidays

Vacation

Parental leave

Paid caregiver leave

Job summary

GSK is seeking a Study Start-up Lead to drive operational strategy and management of start-up activities for global clinical trials across multiple therapies. You will partner with Clinical Operations leaders, LDL, STEP and CRO teams to set priorities and ensure site activation aligns with timelines, budget, and regulatory requirements.

The role requires 3+ years in clinical operations, knowledge of ICH-GCP, and strong leadership in matrix environments.

Qualifications

• Bachelor’s degree or equivalent professional experience in sciences.
• 3+ years of experience in clinical operations or similar positions in the pharmaceutical industry.
• Experience with ICH-GCP, local regulations, and regulatory processes.

Responsibilities

• Ensure timely start-up of all clinical studies across multiple therapeutic areas per timelines, budget, and quality targets.
• Coordinate with central and global teams for study start-up activities.
• Forecast country-specific study start-up timelines and manage site activation.
• Lead site engagement timelines and regulatory package completion as needed.
• Identify process improvements and share best practices.

Skills

Agile Thinking

Business Acumen

Clinical Development

Clinical Research

Clinical Sciences

Clinical Trial Designs

Communication

Creativity

Decision Making

Fostering Collaboration

Good Clinical Practice

Influencing Without Authority

Pharmaceutical Industry

Project Management

Time Management

Education

Bachelor’s degree in Sciences

Job description

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.

Key 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

Basic Qualification

• 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.

Preferred Qualification

• 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

Salary & Benefits

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. 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.

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