Sr. Clinical Trial Manager

Structure Therapeutics•South San Francisco, CA

8d•$171,000 - $218,000

About The Position

Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager to join its Clinical Operations team. The role provides day-to-day oversight of global clinical trials, including management of internal stakeholders, CROs, service providers, clinical monitors, and trial sites. The manager will focus on multinational, multicenter, late-stage studies and may take on additional studies or indications. Working closely with the Clinical Development Operations team, the role ensures assigned deliverables are completed on time and within budget. The position collaborates with cross-functional teams in the US and Shanghai to ensure trials are conducted promptly and in compliance with SOPs, ICH/GCP, country-specific regulatory guidelines, company goals, and budgets. The role manages project goals and supports delivery of quality clinical trials in line with business needs. The anticipated base pay range is $171,000–$218,000. The successful candidate is eligible for an annual performance incentive bonus, new-hire equity, and ongoing performance-based equity. Benefits include medical, dental, and vision insurance, a 401(k) match, unlimited PTO, and paid holidays including a winter shutdown. Travel required: up to 30%.

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 laboratories, and other service providers in global, multinational studies or programs.
PC literacy and proficiency with Microsoft Office applications, 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 is desired, particularly with Asia-Pacific and EU teams.

Responsibilities

Lead and coordinate global cross-functional study teams through study start-up, conduct, and close-out.
Help drive RFP and RFI processes with internal stakeholders; analyze service providers, budgets, and proposals; conduct bid defense meetings; award services; and negotiate and execute complex agreements.
Provide oversight and direction to CROs and service providers to coordinate clinical study activities accurately.
Assist with inspection readiness, including developing, modifying, or implementing policies as needed to ensure quality and integrity in study activities.
Coordinate 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 design, 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 responses.
Manage study sites and study-related activities, including feasibility, selection, start-up, recruitment, enrollment, study management, monitoring report review, site management, trial master files, and data review and cleanup.
Coordinate with the Lead and Finance to track financial status against budget.
Provide regular updates to the Study Lead and other stakeholders, and proactively identify, manage, or escalate issues.
Prepare or review clinical sections of regulatory submissions and responses to ethics committee or health authority questions.
Monitor study progress for scope changes and ensure timely change-order implementation and finalization; implement PI and site monitor training as applicable.
May oversee and manage study budgets, including site and service-provider budgets.
Oversee communication of operational issues and provide accurate progress reports 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.