Sr. Clinical Trial Manager
Structure Therapeutics
11 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Job Responsibilities:
- Lead and coordinate global cross-functional study teams through all study stages (start-up, conduct, close-out).
- Drive RFP/RFI processes; analyze service providers, budgets, and proposals; conduct bid defense meetings; award services; negotiate and execute complex agreements (e.g., CRO, collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Assist with Inspection Readiness; develop/modify/implement policies to ensure 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).
- Follow and improve processes; recommend SOP and policy changes for compliant clinical operations.
- Identify study issues/risks; recommend and 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.
- Coordinate with Lead and Finance to track financial status vs budget; may oversee study budgets.
- Provide regular stakeholder updates; proactively identify/manage/escalate operational issues.
- Ensure study system oversight (EDC, CTMS, eTMF) is current and accurate.
- Contribute as SME to identify and implement process improvements; other supportive duties.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years clinical research/CRA or related experience with increasing responsibility.
- 3+ years study management experience in clinical drug development.
- Experience selecting/managing sites, CROs, specialty labs, and service providers in global multinational studies.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU).
Core Skills/Requirements:
- 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): medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.
- Lead and coordinate global cross-functional study teams through all study stages (start-up, conduct, close-out).
- Drive RFP/RFI processes; analyze service providers, budgets, and proposals; conduct bid defense meetings; award services; negotiate and execute complex agreements (e.g., CRO, collaboration agreements).
- Provide oversight and direction to CROs and service providers to coordinate clinical study activities.
- Assist with Inspection Readiness; develop/modify/implement policies to ensure 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).
- Follow and improve processes; recommend SOP and policy changes for compliant clinical operations.
- Identify study issues/risks; recommend and 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.
- Coordinate with Lead and Finance to track financial status vs budget; may oversee study budgets.
- Provide regular stakeholder updates; proactively identify/manage/escalate operational issues.
- Ensure study system oversight (EDC, CTMS, eTMF) is current and accurate.
- Contribute as SME to identify and implement process improvements; other supportive duties.
Qualifications:
- Bachelor’s degree or equivalent (scientific/healthcare preferred).
- 7+ years clinical research/CRA or related experience with increasing responsibility.
- 3+ years study management experience in clinical drug development.
- Experience selecting/managing sites, CROs, specialty labs, and service providers in global multinational studies.
- Experience supporting SOP development and implementation.
- Global team experience desired (Asia-Pacific and EU).
Core Skills/Requirements:
- 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): medical, dental, vision insurance; 401k match; unlimited PTO; paid holidays including winter shutdown; annual performance incentive bonus; new hire equity; ongoing performance-based equity.