Sr. Clinical Trial Manager
Structure Therapeutics
August 12, 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; focuses on multinational, multicenter, late-stage studies.
Job Responsibilities:
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI process; analyze providers, budgets, and proposals; conduct bid defense meetings; negotiate and execute complex agreements (e.g., CRO and study-related collaboration agreements).
- Provide oversight/direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness; develop/modify/implement policies as needed for quality and integrity.
- Coordinate clinical timelines; escalate issues impacting deliverables.
- Lead/participate in development and review of study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Follow and recommend changes to SOPs/policies to ensure compliant clinical operations.
- Identify, escalate, and recommend/implement mitigations for study risks/issues.
- Manage study sites and activities: feasibility, selection, start-up, subject recruitment/enrollment, monitoring review, site management, TMF, and data review/clean-up.
- Track financial status against budget; coordinate with Lead and Finance.
- Provide regular stakeholder updates; proactively manage/escalate issues.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor study progress for scope changes; support change orders and trainings (e.g., PI/site monitor training).
- Ensure clinical systems oversight (EDC, CTMS, eTMF) for current/accurate data.
Qualifications:
- Bachelor’s degree or equivalent (scientific or healthcare preferred).
- 7+ years industry experience as a Clinical Research Associate or related function with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Skills/Competencies:
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel Required: 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; focuses on multinational, multicenter, late-stage studies.
Job Responsibilities:
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI process; analyze providers, budgets, and proposals; conduct bid defense meetings; negotiate and execute complex agreements (e.g., CRO and study-related collaboration agreements).
- Provide oversight/direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness; develop/modify/implement policies as needed for quality and integrity.
- Coordinate clinical timelines; escalate issues impacting deliverables.
- Lead/participate in development and review of study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Follow and recommend changes to SOPs/policies to ensure compliant clinical operations.
- Identify, escalate, and recommend/implement mitigations for study risks/issues.
- Manage study sites and activities: feasibility, selection, start-up, subject recruitment/enrollment, monitoring review, site management, TMF, and data review/clean-up.
- Track financial status against budget; coordinate with Lead and Finance.
- Provide regular stakeholder updates; proactively manage/escalate issues.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor study progress for scope changes; support change orders and trainings (e.g., PI/site monitor training).
- Ensure clinical systems oversight (EDC, CTMS, eTMF) for current/accurate data.
Qualifications:
- Bachelor’s degree or equivalent (scientific or healthcare preferred).
- 7+ years industry experience as a Clinical Research Associate or related function with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Skills/Competencies:
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel Required: Up to 30%.