Sr. Clinical Trial Manager
Structure Therapeutics
15 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Sr. Clinical Trial Manager (SCTM) to oversee global clinical trials, managing internal stakeholders, CROs, service providers, clinical monitors, and trial sites. Supports multinational, multicenter, late-stage studies and may take on additional studies/indications. Ensures trials are conducted timely and in compliance with SOPs, ICH/GCP, country regulations, goals, and budgets.
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Support RFP/RFI: analyze providers, budgets, proposals; conduct bid defenses; negotiate/execute complex agreements (e.g., CRO and collaborations).
- Provide oversight/direction to CROs and service providers.
- Assist inspection readiness (develop/modify policies as needed).
- Coordinate timelines; escalate risks/issues impacting timelines or deliverables.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plan, TMF plan).
- Recommend updates to SOPs/policies for compliant processes.
- Identify study issues/risks; escalate and recommend/implement mitigation.
- Manage sites and site-related activities (feasibility, selection, start-up, recruitment, enrollment, monitoring review, site management, TMFs, data review/clean-up).
- Track financial status against budget (with Lead and Finance); may oversee study budgets.
- Provide regular stakeholder updates and progress reports.
- Ensure EDC/CTMS/eTMF data and information are current/accurate.
- Contribute as SME to process improvements and standards.
- Perform other supportive duties as assigned.
Qualifications
- Bachelor’s degree or equivalent (scientific or healthcare preferred).
- 7+ years clinical industry experience as CRA or related role 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.
- Experience supporting SOP development/implementation.
- Global team experience desired; Asia-Pacific and EU highly desired.
Required/Preferred Skills
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH Guidelines, and GCP.
Travel: Up to 30%
Sr. Clinical Trial Manager (SCTM) to oversee global clinical trials, managing internal stakeholders, CROs, service providers, clinical monitors, and trial sites. Supports multinational, multicenter, late-stage studies and may take on additional studies/indications. Ensures trials are conducted timely and in compliance with SOPs, ICH/GCP, country regulations, goals, and budgets.
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Support RFP/RFI: analyze providers, budgets, proposals; conduct bid defenses; negotiate/execute complex agreements (e.g., CRO and collaborations).
- Provide oversight/direction to CROs and service providers.
- Assist inspection readiness (develop/modify policies as needed).
- Coordinate timelines; escalate risks/issues impacting timelines or deliverables.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plan, TMF plan).
- Recommend updates to SOPs/policies for compliant processes.
- Identify study issues/risks; escalate and recommend/implement mitigation.
- Manage sites and site-related activities (feasibility, selection, start-up, recruitment, enrollment, monitoring review, site management, TMFs, data review/clean-up).
- Track financial status against budget (with Lead and Finance); may oversee study budgets.
- Provide regular stakeholder updates and progress reports.
- Ensure EDC/CTMS/eTMF data and information are current/accurate.
- Contribute as SME to process improvements and standards.
- Perform other supportive duties as assigned.
Qualifications
- Bachelor’s degree or equivalent (scientific or healthcare preferred).
- 7+ years clinical industry experience as CRA or related role 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.
- Experience supporting SOP development/implementation.
- Global team experience desired; Asia-Pacific and EU highly desired.
Required/Preferred Skills
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH Guidelines, and GCP.
Travel: Up to 30%