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About the Role
Structure Therapeutics is seeking a highly motivated Sr. Clinical Trial Manager (SCTM) to join our Clinical Operations team. This role offers a unique opportunity to contribute to a growing company focused on developing life-changing small molecule medicines. The SCTM will oversee global clinical trials, manage internal stakeholders, CROs, service providers, monitors, and sites, with a focus on multinational, late-stage studies. This position involves close collaboration with a cross-functional team to ensure timely and compliant clinical trial execution within budget.
Responsibilities
- Lead and coordinate global cross-functional study teams through all study stages.
- Drive the RFP and RFI process, analyze service providers, budgets, and proposals.
- Negotiate and execute complex agreements with CROs and other service providers.
- Provide oversight and direction to CROs and service providers for clinical study activities.
- Assist with Inspection Readiness activities and policy development.
- Coordinate clinical study timelines and escalate issues impacting deliverables.
- Lead and/or participate in the development and review of study documents.
- Recommend changes to SOPs and policies for compliant processes.
- Identify, escalate, and implement solutions for study issues/risks.
- Manage study sites and related activities, including feasibility, start-up, recruitment, enrollment, and data review.
- Track financial status against budget in coordination with Lead and Finance.
- Provide regular updates and progress reports to stakeholders.
- Prepare or review clinical sections of regulatory submission documents and responses to health authorities.
- Monitor study progress for scope changes and ensure timely change order implementation.
- Oversee and manage study budgets, including site and service provider budgets.
- Ensure ongoing communication of operational issues and provide progress reports.
- Ensure data and information in study-specific systems are current and accurate.
- Lead cooperative efforts on project teams or act as a subject matter expert for process improvements.
- Perform other supportive duties as assigned.
Requirements
- Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
- Minimum of 7+ years of related industry experience as a Clinical Research Associate or related function.
- Minimum of 3+ years 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.
- Experience in supporting SOP development and implementation.
- Experience working on global teams is desired (Asia-Pacific and EU highly).
- In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP requirements.
Skills
- PC literacy
- MSOffice skills (Outlook, Word, Excel, PowerPoint)
Location
- California
- Shanghai
Work Type
- Full-time
Experience Level
- Senior
- 7+ years of related industry experience
- 3+ years study management experience
Education Level
- Bachelor's degree or equivalent
Salary/Compensations
- $171,000 - $218,000
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- 401k match
- Unlimited PTO
- Paid holidays
- Winter shutdown
- Annual performance incentive bonus
- New hire equity
- Ongoing performance-based equity
About the Company
- Structure Therapeutics develops life-changing medicines using advanced structure-based and computational drug discovery technology.
- The company's platform combines visualization of molecular interactions, computational chemistry, and data integration to design orally available small molecule medicines.
- Structure Therapeutics is advancing a clinical-stage pipeline focused on chronic diseases with high unmet need.
- The company is led by experienced international drug innovators and financed by top-tier global life sciences investors.
- Structure Therapeutics completed an IPO in February 2023.
- With offices in California and Shanghai, the company benefits from being at the center of life science innovation in both the US and China.
Equal Opportunity
- Structure Therapeutics Inc. is an Equal-Opportunity Employer.
- Structure Therapeutics is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive.