Sr. Clinical Trial Manager (MP)
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.
- Drive RFP/RFI process, analyze service providers/budgets/proposals, conduct bid defenses, and negotiate/execute complex agreements (e.g., CRO and collaboration agreements).
- Oversee CRO and service providers to coordinate clinical study activities.
- Support Inspection Readiness activities; develop/modify/implement policies to ensure study quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Follow and recommend updates to SOPs/policies to ensure compliant clinical operations.
- Identify study issues/risks and recommend/implement mitigations.
- Manage study sites and activities: feasibility/selection/start-up, subject recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean-up.
- Track financial status against budget; coordinate with Lead and Finance.
- Provide regular stakeholder updates; proactively identify/manage/escalate issues.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress for scope changes and support change order implementation, PI/site monitor training.
- Oversee study budget (sites and service providers) as needed.
- Ensure study-system data is current/accurate (EDC, CTMS, eTMF).
- Lead/participate as SME to implement process improvements; other duties as assigned.
Qualifications
- Bachelor’s degree (scientific or healthcare preferred).
- 7+ years industry experience as 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 programs.
- Experience supporting SOP development/implementation.
- Global team experience desired; Asia-Pacific and EU highly preferred.
Required Skills/Competencies
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH GCP.
Benefits (as stated)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, vision; 401(k) match; unlimited PTO; paid holidays including winter shutdown.
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI process, analyze service providers/budgets/proposals, conduct bid defenses, and negotiate/execute complex agreements (e.g., CRO and collaboration agreements).
- Oversee CRO and service providers to coordinate clinical study activities.
- Support Inspection Readiness activities; develop/modify/implement policies to ensure study quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (CRF design, project plans, service provider oversight plans, TMF plan).
- Follow and recommend updates to SOPs/policies to ensure compliant clinical operations.
- Identify study issues/risks and recommend/implement mitigations.
- Manage study sites and activities: feasibility/selection/start-up, subject recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean-up.
- Track financial status against budget; coordinate with Lead and Finance.
- Provide regular stakeholder updates; proactively identify/manage/escalate issues.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress for scope changes and support change order implementation, PI/site monitor training.
- Oversee study budget (sites and service providers) as needed.
- Ensure study-system data is current/accurate (EDC, CTMS, eTMF).
- Lead/participate as SME to implement process improvements; other duties as assigned.
Qualifications
- Bachelor’s degree (scientific or healthcare preferred).
- 7+ years industry experience as 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 programs.
- Experience supporting SOP development/implementation.
- Global team experience desired; Asia-Pacific and EU highly preferred.
Required Skills/Competencies
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH GCP.
Benefits (as stated)
- Annual performance incentive bonus; new hire equity; ongoing performance-based equity; medical, dental, vision; 401(k) match; unlimited PTO; paid holidays including winter shutdown.