Sr. Clinical Trial Manager
Structure Therapeutics
16 days ago
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.
- Drive RFP/RFI processes, analyze providers/budgets/proposals, conduct bid defenses, and negotiate/execute complex agreements (e.g., CRO, collaboration agreements).
- Provide oversight and direction to CROs and service providers.
- Support inspection readiness (policies/modifications as needed) to ensure trial quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Lead/participate in development and review of study documents (CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant processes.
- Identify study issues/risks; escalate and recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, monitoring review, site management, TMF, and data review/clean-up).
- Track financial status against budget with Lead and Finance; provide progress updates to stakeholders.
- Prepare/review clinical sections of regulatory submissions; respond to EC and/or Health Authority questions.
- Monitor progress for scope changes and change order implementation; support training rollouts (e.g., PI/site monitor training).
- Ensure EDC/CTMS/eTMF systems data are current and accurate.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years related industry experience as Clinical Research Associate (or related), with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing global study sites, CROs, specialty labs, and service providers.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Required/Preferred Skills:
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Benefits (as stated):
- Annual performance incentive bonus; new hire equity and ongoing performance-based equity.
- Medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI processes, analyze providers/budgets/proposals, conduct bid defenses, and negotiate/execute complex agreements (e.g., CRO, collaboration agreements).
- Provide oversight and direction to CROs and service providers.
- Support inspection readiness (policies/modifications as needed) to ensure trial quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Lead/participate in development and review of study documents (CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant processes.
- Identify study issues/risks; escalate and recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, monitoring review, site management, TMF, and data review/clean-up).
- Track financial status against budget with Lead and Finance; provide progress updates to stakeholders.
- Prepare/review clinical sections of regulatory submissions; respond to EC and/or Health Authority questions.
- Monitor progress for scope changes and change order implementation; support training rollouts (e.g., PI/site monitor training).
- Ensure EDC/CTMS/eTMF systems data are current and accurate.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years related industry experience as Clinical Research Associate (or related), with increasing responsibility.
- 3+ years study management experience in clinical/drug development.
- Experience selecting/managing global study sites, CROs, specialty labs, and service providers.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Required/Preferred Skills:
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Benefits (as stated):
- Annual performance incentive bonus; new hire equity and ongoing performance-based equity.
- Medical/dental/vision insurance, 401k match, unlimited PTO, and paid holidays including winter shutdown.