Clinical Trial Manager/Local Delivery Lead

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.

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This is a remote home-based role for applicants eligible to work in the United States.

Would you like to be part of GSK's emerging clinical leadership, with an opportunity to accelerate clinical operations on a national scale? If so, this could be an excellent opportunity to explore.

The Clinical Trial Manager/Local Delivery Lead provides endtoend leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations. It is accountable for achieving recruitment (including patient representation), timelines, budget, quality, and regulatory compliance while leading a highly matrixed, crossfunctional team of internal stakeholders, vendors, and investigative sites. The role drives proactive risk management, continuous improvement, and highquality decisionmaking.

Key Responsibilities:

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Accountable for delivery of assigned studies to recruitment targets, patient representation targets, time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations.

• Leads the local study team consisting of US clinical operations team members, cross functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery, providing both matrix leadership and project management of study activities within the United States.

• Serves as the operational point-of-contact between the central GSK study team and US study team. Collaborate closely with local medical and regulatory affairs staff to align local medical and scientific requirements, IND/GCP/ICH guidelines,

• Proactively identifies, resolves, and/or escalates risks and issues that may impact study delivery, providing effective troubleshooting and problemresolution support to ensure efficient and productive study execution.

• Accountable for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders

• Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity.

• Has the curiosity to understand the why and the courage to challenge the how.

• Acquires and maintains an appropriate level of knowledge on the study compound, protocol, study indication(s), pathology of disease area being studied, competitive landscape within the US, local treatment/immunization guidelines and local health care system requirements.

• Excellent matrix leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.

• Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment.

• Provides feedback on performance, capabilities and competencies of study members to line management.

• Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.

• Accountable to estimate, track and deliver against the local budget for the studies within their scope of responsibility.

• Demonstrates track record in quality decision-making and problem resolution. Able to set and manage priorities, resource and performance targets of local study deliverables. As required, assists with audits/inspections of local clinical operations department and study / sites in the US.

• As required, prepares the local Informed Consent Form and coordinates the submission of Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs). Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study.

• Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards.

Why You?

Basic Qualifications:

We are seeking professionals with the following required skills and qualifications to help us achieve our goals:

• Bachelor's degree

• 5+ years of experience as a clinical trial manager/local delivery lead managing Medicine trials.

• Phase I-III Medicines trial experience with solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug development process.

• Experience with leading and managing multiple complex design studies such as master protocols of umbrella, basket and platform trial designs.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Master of Science, PhD or equivalent coupled with previous project management experience.

• Medicines trial experience in Oncology and/or Respiratory therapeutic areas.

• Effective problem solving, negotiation and conflict resolution skills in a matrix environment

• Deep knowledge of human research regulations in the US, IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines

• Available and willing to travel as job requires.

• Strong written and verbal communications skills.

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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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at HR.AmericasSC-CS@gsk.com where you can also request a call.

Please note should your inquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive

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.

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