Clinical Trial Manager/Local Delivery Lead

About the role

The Clinical Trial Manager/Local Delivery Lead provides end-to-end 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, cross-functional team of internal stakeholders, vendors, and investigative sites.

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.
• Manages multiple priorities and responsibilities of increasing scope and complexity, demonstrating the ability to set and manage priorities, resource and performance targets of local study deliverables.
• 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.
• Estimates, tracks, and delivers against the local budget for the studies within their scope of responsibility.
• Demonstrates track record in quality decision-making and problem resolution.

Requirements

This role requires a 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.

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.

Skills

• Able to set and manage priorities, resource and performance targets of local study deliverables.
• 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.
• Strong written and verbal communications skills.
• 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.
• 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.
• 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.

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.

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.

Schedule

Remote home-based role.