Sr. Clinical Trial Manager
Structure Therapeutics
August 23, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position: Sr. Clinical Trial Manager (SCTM), Clinical Operations
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI and service provider selection; support bid defenses; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Oversee CROs and service providers; support inspection readiness; ensure SOP/ICH-GCP-aligned study conduct.
- Coordinate clinical timelines; escalate risks/issues impacting milestones/deliverables.
- Develop/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Manage study sites and activities: feasibility/selection, start-up, recruitment/enrollment, monitoring report review, trial master files, and data review/clean-up.
- Track financial status vs. budget; provide regular progress updates; ensure EDC/CTMS/eTMF data accuracy.
- Prepare/review clinical sections for regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress for scope changes; support training implementation (PI/site monitor).
Qualifications
- Bachelor’s degree (scientific/healthcare preferred).
- 7+ years clinical research/CRA-related experience with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience overseeing sites, CROs, specialty labs, and service providers in global, multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU preferred).
Core Skills/Knowledge
- MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%.
Benefits (if applicable): medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI and service provider selection; support bid defenses; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Oversee CROs and service providers; support inspection readiness; ensure SOP/ICH-GCP-aligned study conduct.
- Coordinate clinical timelines; escalate risks/issues impacting milestones/deliverables.
- Develop/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Manage study sites and activities: feasibility/selection, start-up, recruitment/enrollment, monitoring report review, trial master files, and data review/clean-up.
- Track financial status vs. budget; provide regular progress updates; ensure EDC/CTMS/eTMF data accuracy.
- Prepare/review clinical sections for regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress for scope changes; support training implementation (PI/site monitor).
Qualifications
- Bachelor’s degree (scientific/healthcare preferred).
- 7+ years clinical research/CRA-related experience with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience overseeing sites, CROs, specialty labs, and service providers in global, multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU preferred).
Core Skills/Knowledge
- MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%.
Benefits (if applicable): medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.