Sr. Clinical Trial Manager (NS)
Structure Therapeutics
June 25, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Support RFP/RFI processes; analyze service provider budgets/proposals; conduct bid defenses; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness activities, including policy development/modification/implementation as needed.
- Coordinate clinical study timelines with project management; escalate issues impacting timelines/deliverables.
- Lead and/or participate in development and review of study documents (CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend changes to SOPs/policies to ensure compliant clinical operations.
- Identify and escalate study issues/risks; recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, study management, monitoring report review, TMF, and data review/cleanup).
- Track study financial status against budget with Lead/Finance.
- Provide regular stakeholder updates; proactively manage/escalate operational issues.
- Ensure EDC, CTMS, and eTMF data/information is current and accurate.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor study progress for scope changes; support PI and site monitor training.
- Support oversight/management of study budget (sites and service providers) as needed.
- Supervise operational communications and provide progress reports; contribute to process improvements.
- Other supportive duties as assigned.
Qualifications
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years related 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 sites, CROs, specialty labs, and service providers in global, multinational studies/programs.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU preferred).
Core Competencies / Skills
- PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP.
Travel Required
- Up to 30%.
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Support RFP/RFI processes; analyze service provider budgets/proposals; conduct bid defenses; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness activities, including policy development/modification/implementation as needed.
- Coordinate clinical study timelines with project management; escalate issues impacting timelines/deliverables.
- Lead and/or participate in development and review of study documents (CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend changes to SOPs/policies to ensure compliant clinical operations.
- Identify and escalate study issues/risks; recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, study management, monitoring report review, TMF, and data review/cleanup).
- Track study financial status against budget with Lead/Finance.
- Provide regular stakeholder updates; proactively manage/escalate operational issues.
- Ensure EDC, CTMS, and eTMF data/information is current and accurate.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor study progress for scope changes; support PI and site monitor training.
- Support oversight/management of study budget (sites and service providers) as needed.
- Supervise operational communications and provide progress reports; contribute to process improvements.
- Other supportive duties as assigned.
Qualifications
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years related 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 sites, CROs, specialty labs, and service providers in global, multinational studies/programs.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU preferred).
Core Competencies / Skills
- PC literacy; MS Office skills (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA and EU regulations, ICH Guidelines, and GCP.
Travel Required
- Up to 30%.
Benefits
- Medical, dental, and vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.