Sr. Clinical Trial Manager

Structure Therapeutics•South San Francisco, CA

About The Position

Structure Therapeutics is seeking a highly motivated Senior Clinical Trial Manager (SCTM) to join its Clinical Operations team. The company develops small-molecule medicines using structure-based and computational drug discovery technology and is advancing a clinical-stage pipeline focused on chronic cardiovascular, metabolic, and pulmonary conditions with high unmet need. The SCTM is responsible for day-to-day oversight of global clinical trials, including multinational, multicenter, late-stage studies, and may take on additional studies or indications. The role manages internal stakeholders, CROs, service providers, clinical monitors, and trial sites, and works closely with the Clinical Development Operations team and cross-functional colleagues in the US and Shanghai. The SCTM receives objectives and ensures deliverables are completed on time and within budget, in compliance with SOPs, ICH/GCP, country-specific regulatory guidelines, company goals, and budgets. The role may also oversee study budgets and contribute to project initiatives and process improvements. The position requires up to 30% travel. The anticipated base salary range is $171,000–$218,000, with the exact offer dependent on factors such as geography, qualifications, skills, and experience. Eligible compensation includes an annual performance incentive bonus, new-hire equity, and ongoing performance-based equity.

Requirements

Bachelor’s degree or equivalent; a scientific or healthcare discipline is preferred.
At least 7 years of related industry experience as a Clinical Research Associate or in a related function, with increasing responsibility and scope.
At least 3 years of study management experience in clinical and drug development.
Experience selecting, managing, and overseeing sites, CROs, specialty labs, and other service providers in global, multinational studies or programs.
PC literacy and proficiency with Microsoft Office, including Outlook, Word, Excel, and PowerPoint.
In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements governing clinical trials.
Ability to travel up to 30%.

Nice To Haves

Experience supporting SOP development and implementation.
Experience working on global teams, particularly in Asia-Pacific and the EU.

Responsibilities

Lead and coordinate global cross-functional study teams through study start-up, conduct, and close-out.
Help drive RFP and RFI processes; analyze service providers, budgets, and proposals; conduct bid-defense meetings; award services; and negotiate and execute agreements such as CRO and study-related collaboration agreements.
Oversee and direct CROs and service providers to coordinate clinical study activities accurately.
Assist with inspection-readiness activities, including developing, modifying, or implementing policies to ensure study quality and integrity.
Coordinate clinical study timelines with Project Management and escalate issues that may affect timelines or deliverables.
Lead or participate in developing and reviewing study documents, including CRF designs, project plans, Service Provider Oversight plans, and TMF plans.
Follow processes and procedures and recommend changes to SOPs and policies to support comprehensive, compliant clinical operations processes.
Identify potential study issues and risks, escalate them as needed, and recommend or implement appropriate actions.
Manage study sites and related activities, including feasibility, selection, start-up, subject recruitment and enrollment, study management, monitoring report review, site management, trial master files, and data review and clean-up.
Coordinate with the Lead and Finance to track financial status against budget.
Provide regular updates to the Study Lead and stakeholders; proactively identify, manage, or escalate issues appropriately.
Prepare or review clinical sections of regulatory submission documents and responses to ethics committee or health authority questions.
Monitor study progress for potential scope changes and ensure timely change-order implementation and finalization; implement principal investigator and site-monitor training.
May oversee and manage study budgets, including site and service-provider budgets.
Communicate operational issues and provide accurate progress reports on assigned activities to the Study Management Team and Clinical Development Team.
Ensure data and information in study-specific systems, including EDC, CTMS, and eTMF, are current and accurate.
May lead cooperative project-team efforts or contribute as a subject matter expert to projects and initiatives that identify and implement process improvements and standards.
Perform other supportive duties as assigned to achieve operational objectives.