Clinical Trial Manager

About Us

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The companys platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions.

Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Position Summary

Structure Therapeutics is seeking a highly motivated Clinical Trial Manager (CTM) to be part of our Clinical Operations team. This is a unique opportunity to join a growing company committed to converting biologics and peptides into life-changing small molecule medicines for everyone. The CTM will be responsible for the day-to-day oversight of global clinical trials and will manage internal stakeholders, CROs, multiple service providers, clinical monitors, and clinical trial sites.

The CTM will focus on the management and support of multinational, multicenter Phase II studies and may assume responsibility for additional studies, as applicable. The CTM works closely with and supports the Clinical Development Operations team, receives assignments in the form of objectives, and will ensure deliverables are completed on time and within budget.

This position will also work closely with a cross-functional team based in the US and Shanghai to ensure that clinical trials are conducted in a timely fashion and compliant with SOPs, ICH, GCP, country-specific regulatory guidelines, company goals, and budgets. The CTM will be responsible for managing various project goals and supporting delivery of a quality clinical trial to meet current business needs and trends.

Job Responsibilities

• Leads and coordinates global cross-functional study teams through all study stages, start-up, conduct, close-out.
• In collaboration with internal stakeholders, responsible for helping to drive the RFP and RFI process, analyze service providers budgets and proposals, conduct bid defense meetings, award services, negotiate, and execute complex agreements (e.g., CRO study-related collaboration agreements).
• Provides oversight and direction to the CRO and service providers to accurately coordinate clinical study activities.
• Assists with Inspection Readiness activities, which may require the development, modification, and/or implementation of policies as needed to ensure high quality and integrity in all study activities.
• Coordinates clinical study timelines with Project Management and escalates issues that may impact timelines, deliverables.
• Leads and/or participates in the development and review of study documents, including but not limited to CRF design, project plans, Service Provider Oversight plans, TMF plan.
• Follows processes and procedures and recommends changes to SOPs and policies to ensure comprehensive and compliant processes in the clinical operations organization.
• Identifies potential study issues, risks, escalates as needed, and recommends implements changes.
• Manages study sites and study-related activities, including but not limited to site feasibility selection, start-up, subject recruitment, enrollment, study management, monitoring, report review, site management, trial master files, and data review, clean-up.
• Coordinates with Lead and Finance to track the financial status against budget.
• Provides regular updates to Study Lead and other stakeholders.
• Proactively identifies, manages, or escalates issues appropriately.
• Prepares or reviews clinical sections of regulatory submission documents, responses to EC and/or Health Authority questions.
• Monitors study progress for possible changes in study scope to ensure timely change order implementation and finalization.
• Implements PI Training, site monitor training, etc.
• May have some responsibility for the oversight and management of the study budget, including site and service provider budgets.
• Supervises ongoing communication of operational issues and provides accurate progress reports on assigned activities to Study Management Team and Clinical Development Team.
• Ensures oversight of data and information in study-specific systems (EDC, CTMS, eTMF) is current and accurate.
• May lead a cooperative effort on a project team or contribute as a subject matter expert on key projects and initiatives to identify and implement process improvements and standards.
• Other supportive duties as assigned to achieve operational goals.

Qualifications

Education

• Bachelors degree or equivalent scientific or healthcare discipline preferred

Experience

• Minimum of 3 years of related industry experience as a Clinical Research Associate or related function with increasing responsibility and scope
• Minimum of 1 year of study management experience in clinical and drug development
• Experience in selecting, managing, and overseeing sites, CROs, specialty labs, and other service providers in global, multinational studies or programs
• Experience in supporting SOP development and implementation
• Experience working on global teams is desired (Asia-Pacific and EU highly)
• Must have high-quality written and oral communication skills with the ability to convey overall objectives and maintain open lines of communication between internal stakeholders and service providers
• Must have negotiation and project management skills with the ability to coordinate across projects, programs, timelines
• Ability to integrate into and collaborate effectively with a remote, cross-functional team environment (US, APAC, EU) with a positive attitude
• Ability to prioritize and handle multiple activities daily, yet flexible and responsive to frequently shifting priorities

Core Competencies, Knowledge, and Skill Requirements

• PCL literacy required
• MS Office skills
• Outlook, Word, Excel, PowerPoint

In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements governing the conduct of clinical trials

Travel Required

Up to 30

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices and strives to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $146,000 - $185,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidates geography, qualifications, skills, and experience.

At Structure Therapeutics, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Structure Therapeutics also offers various benefits, including but not limited to medical, dental, and vision insurance, 401(k) match, unlimited PTO, and a number of paid holidays, including winter shutdown.

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