Sr. Clinical Trial Manager
Structure Therapeutics
September 01, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary:
Sr. Clinical Trial Manager (SCTM) responsible for day-to-day oversight of global clinical trials, managing internal stakeholders, CROs, service providers, clinical monitors, and trial sites. Supports multinational, multicenter, late-stage studies; ensures deliverables are completed on time and within budget and conducted in compliance with SOPs, ICH/GCP, country-specific regulations, and company goals.
Job Responsibilities:
- Lead/coordinate global cross-functional study teams across start-up, conduct, and close-out.
- Support RFP/RFI processes; analyze providers/budgets/proposals; conduct bid defenses; negotiate/execute complex agreements (e.g., CRO, collaborations).
- Oversee CRO and service providers to coordinate clinical study activities.
- Support inspection readiness activities (policies/processes for quality and integrity).
- Coordinate clinical timelines; escalate issues impacting timelines/deliverables.
- Lead/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant processes.
- Identify risks/issues; recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection/start-up, recruitment/enrollment, monitoring report review, site management, TMF, data review/clean-up).
- Track financial status vs. budget with Lead/Finance; provide progress updates; manage/escalate operational issues.
- Prepare/review clinical sections for regulatory submissions and responses to EC and Health Authorities.
- Monitor scope changes and support change order implementation (including training such as PI/site monitor).
- Ensure EDC/CTMS/eTMF data is current and accurate.
- Lead or contribute to process improvement initiatives; other supportive duties as assigned.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years clinical research experience (CRA or related) with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers for multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Core Competencies/Skills:
- PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel:
- Up to 30%.
Sr. Clinical Trial Manager (SCTM) responsible for day-to-day oversight of global clinical trials, managing internal stakeholders, CROs, service providers, clinical monitors, and trial sites. Supports multinational, multicenter, late-stage studies; ensures deliverables are completed on time and within budget and conducted in compliance with SOPs, ICH/GCP, country-specific regulations, and company goals.
Job Responsibilities:
- Lead/coordinate global cross-functional study teams across start-up, conduct, and close-out.
- Support RFP/RFI processes; analyze providers/budgets/proposals; conduct bid defenses; negotiate/execute complex agreements (e.g., CRO, collaborations).
- Oversee CRO and service providers to coordinate clinical study activities.
- Support inspection readiness activities (policies/processes for quality and integrity).
- Coordinate clinical timelines; escalate issues impacting timelines/deliverables.
- Lead/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant processes.
- Identify risks/issues; recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection/start-up, recruitment/enrollment, monitoring report review, site management, TMF, data review/clean-up).
- Track financial status vs. budget with Lead/Finance; provide progress updates; manage/escalate operational issues.
- Prepare/review clinical sections for regulatory submissions and responses to EC and Health Authorities.
- Monitor scope changes and support change order implementation (including training such as PI/site monitor).
- Ensure EDC/CTMS/eTMF data is current and accurate.
- Lead or contribute to process improvement initiatives; other supportive duties as assigned.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years clinical research experience (CRA or related) with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers for multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Core Competencies/Skills:
- PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel:
- Up to 30%.