Sr. Clinical Trial Manager
Structure Therapeutics
10 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position Summary
Sr. Clinical Trial Manager (SCTM) responsible for day-to-day oversight of global clinical trials; manages internal stakeholders, CROs, service providers, clinical monitors, and clinical trial sites. Oversees multinational, multicenter Phase II studies and may assume responsibility for additional studies/indications.
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI activities, analyze providers/budgets/proposals, conduct bid defense meetings, and negotiate/execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs/service providers to coordinate clinical study activities.
- Support Inspection Readiness; develop/modify/implement policies to ensure quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plans, TMF plan).
- Recommend SOP and policy changes to ensure compliant processes.
- Identify, escalate, and recommend/implement study risks/issues.
- Manage sites and activities: feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean-up.
- Track financial status against budget with Lead and Finance; may oversee study budget.
- Provide regular stakeholder updates and progress reports.
- Ensure EDC/CTMS/eTMF systems data are current and accurate.
- Lead or contribute as SME to process improvements/standards.
Qualifications
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years clinical research/CRA or related experience with increasing responsibility.
- 3+ years clinical study management experience.
- Experience selecting/managing global sites, CROs, specialty labs, and service providers in multinational studies.
- Experience supporting SOP development and implementation.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel Required: Up to 30%
Sr. Clinical Trial Manager (SCTM) responsible for day-to-day oversight of global clinical trials; manages internal stakeholders, CROs, service providers, clinical monitors, and clinical trial sites. Oversees multinational, multicenter Phase II studies and may assume responsibility for additional studies/indications.
Job Responsibilities
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI activities, analyze providers/budgets/proposals, conduct bid defense meetings, and negotiate/execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs/service providers to coordinate clinical study activities.
- Support Inspection Readiness; develop/modify/implement policies to ensure quality and integrity.
- Coordinate clinical study timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (e.g., CRF design, project plans, service provider oversight plans, TMF plan).
- Recommend SOP and policy changes to ensure compliant processes.
- Identify, escalate, and recommend/implement study risks/issues.
- Manage sites and activities: feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean-up.
- Track financial status against budget with Lead and Finance; may oversee study budget.
- Provide regular stakeholder updates and progress reports.
- Ensure EDC/CTMS/eTMF systems data are current and accurate.
- Lead or contribute as SME to process improvements/standards.
Qualifications
- Bachelor’s degree (scientific or healthcare discipline preferred).
- 7+ years clinical research/CRA or related experience with increasing responsibility.
- 3+ years clinical study management experience.
- Experience selecting/managing global sites, CROs, specialty labs, and service providers in multinational studies.
- Experience supporting SOP development and implementation.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel Required: Up to 30%