Sr. Clinical Trial Manager
Structure Therapeutics
10 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Position: Sr. Clinical Trial Manager (SCTM)
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; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Support Inspection Readiness activities (policies/processes 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 changes to SOPs/policies for compliant clinical operations.
- Identify study issues/risks; escalate and recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/cleanup).
- Track financial status against budget with Lead and Finance.
- Provide regular progress updates; proactively manage/escalate operational issues.
- Ensure EDC/CTMS/eTMF data and information are current and accurate.
- Lead or contribute as SME for process improvements and standards.
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/overseeing sites, CROs, labs, and other providers in global multinational studies.
- Experience supporting SOP development and implementation.
- Global team experience desired; Asia-Pacific and EU experience highly desired.
Skills/Required Competencies
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%
Benefits (as stated)
- Annual performance incentive bonus; new hire equity and performance-based equity; medical, dental, vision; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).
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; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Support Inspection Readiness activities (policies/processes 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 changes to SOPs/policies for compliant clinical operations.
- Identify study issues/risks; escalate and recommend/implement mitigations.
- Manage study sites and activities (feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/cleanup).
- Track financial status against budget with Lead and Finance.
- Provide regular progress updates; proactively manage/escalate operational issues.
- Ensure EDC/CTMS/eTMF data and information are current and accurate.
- Lead or contribute as SME for process improvements and standards.
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/overseeing sites, CROs, labs, and other providers in global multinational studies.
- Experience supporting SOP development and implementation.
- Global team experience desired; Asia-Pacific and EU experience highly desired.
Skills/Required Competencies
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth understanding of FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%
Benefits (as stated)
- Annual performance incentive bonus; new hire equity and performance-based equity; medical, dental, vision; 401(k) match; unlimited PTO; paid holidays (including winter shutdown).