Sr. Clinical Trial Manager (MP)
Structure Therapeutics
June 30, 2026
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Manage multinational, multicenter late-stage studies; oversee CROs and service providers to ensure accurate coordination of clinical activities.
- Support RFP/RFI processes; analyze bids, budgets, and proposals; conduct bid defenses; negotiate and execute complex agreements.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plans, TMF plan) and ensure SOP/compliance alignment (ICH/GCP; country regulatory requirements).
- Oversee clinical sites (feasibility, selection, start-up, recruitment/enrollment, monitoring report review, TMF and data review/clean-up).
- Track financial status vs. budget; coordinate timelines with project management and escalate risks impacting deliverables.
- Prepare/review clinical sections for regulatory submissions and responses to EC/Health Authority questions.
- Ensure EDC/CTMS/eTMF systems data are current and accurate; support inspection readiness activities.
Qualifications:
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years industry experience (Clinical Research Associate or related), with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience managing sites/CROs/specialty labs/service providers in global multinational studies.
- Experience supporting SOP development/implementation.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of FDA/EU regulations, ICH, and GCP.
- Global team experience desired (Asia-Pacific and EU preferred).
Benefits:
- Medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Travel: Up to 30%.
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Manage multinational, multicenter late-stage studies; oversee CROs and service providers to ensure accurate coordination of clinical activities.
- Support RFP/RFI processes; analyze bids, budgets, and proposals; conduct bid defenses; negotiate and execute complex agreements.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plans, TMF plan) and ensure SOP/compliance alignment (ICH/GCP; country regulatory requirements).
- Oversee clinical sites (feasibility, selection, start-up, recruitment/enrollment, monitoring report review, TMF and data review/clean-up).
- Track financial status vs. budget; coordinate timelines with project management and escalate risks impacting deliverables.
- Prepare/review clinical sections for regulatory submissions and responses to EC/Health Authority questions.
- Ensure EDC/CTMS/eTMF systems data are current and accurate; support inspection readiness activities.
Qualifications:
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years industry experience (Clinical Research Associate or related), with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience managing sites/CROs/specialty labs/service providers in global multinational studies.
- Experience supporting SOP development/implementation.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of FDA/EU regulations, ICH, and GCP.
- Global team experience desired (Asia-Pacific and EU preferred).
Benefits:
- Medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown.
Travel: Up to 30%.