Clinical Trial Manager/Local Delivery Lead

About the role

The Clinical Trial Manager/Local Delivery Lead role is a remote home-based position within GSK. This role provides end-to-end leadership for US clinical study delivery, serving as the primary operational link between global study teams and local US operations.

Responsibilities

• 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.
• Demonstrates the ability to leverage AI and digital tools to solve complex problems, streamline processes, improve decision-making, and enhance efficiency for both individual work and broader team operations.
• Proactively identifies, resolves, and/or escalates risks and issues that may impact study delivery, providing effective troubleshooting and problem-resolution support to ensure efficient and productive study execution.
• Accounts for the accuracy of study systems, including completeness of the trial master file, and reporting study delivery progress to study team and key stakeholders.
• 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.
• Exhibits 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.

Qualifications

• Bachelor’s degree: BA or BS OR 10+ years of clinical/clinical operations experience
• At least 5 years’ experience as a local trial manager/local delivery lead managing Oncology 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.
• 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