Clinical Trial Manager
Structure Therapeutics
9 days ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Clinical Trial Manager (CTM) — Job Responsibilities:
- Lead and coordinate global cross-functional study teams through start-up, conduct, and close-out.
- Drive RFP/RFI processes; analyze service providers, budgets, and proposals; conduct bid defense meetings; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight/direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness (policy development/modification as needed).
- Coordinate clinical timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (e.g., CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant, comprehensive processes.
- Identify study risks/issues; recommend/implement mitigations.
- Manage study sites and activities: feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean up.
- Track financial status vs. budget (with Lead and Finance); may manage study budget oversight.
- Provide regular stakeholder updates; report progress and escalate appropriately.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress and support scope changes/change orders and PI/site monitor training.
- Ensure EDC/CTMS/eTMF data and information are current and accurate.
- Other supportive duties as assigned.
Qualifications:
- Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
- 3+ years industry experience as Clinical Research Associate or related function with increasing responsibility.
- 1+ year study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers in multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Required/Preferred Skills:
- High-quality written/oral communication; strong negotiation and project management.
- Ability to collaborate in a remote cross-functional environment; prioritize multiple activities and adapt to shifting priorities.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%.
Benefits (if offered): annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, 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 service providers, budgets, and proposals; conduct bid defense meetings; negotiate and execute complex agreements (e.g., CRO and collaboration agreements).
- Provide oversight/direction to CROs and service providers to coordinate clinical study activities.
- Support inspection readiness (policy development/modification as needed).
- Coordinate clinical timelines; escalate issues impacting timelines/deliverables.
- Develop/review study documents (e.g., CRF design, project plans, Service Provider Oversight plans, TMF plan).
- Recommend SOP/policy changes to ensure compliant, comprehensive processes.
- Identify study risks/issues; recommend/implement mitigations.
- Manage study sites and activities: feasibility, selection, start-up, recruitment/enrollment, monitoring report review, site management, TMF, and data review/clean up.
- Track financial status vs. budget (with Lead and Finance); may manage study budget oversight.
- Provide regular stakeholder updates; report progress and escalate appropriately.
- Prepare/review clinical sections of regulatory submissions and responses to EC/Health Authority questions.
- Monitor progress and support scope changes/change orders and PI/site monitor training.
- Ensure EDC/CTMS/eTMF data and information are current and accurate.
- Other supportive duties as assigned.
Qualifications:
- Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
- 3+ years industry experience as Clinical Research Associate or related function with increasing responsibility.
- 1+ year study management experience in clinical/drug development.
- Experience selecting/managing/overseeing global sites, CROs, specialty labs, and service providers in multinational studies.
- Experience supporting SOP development/implementation.
- Global team experience desired (Asia-Pacific and EU highly preferred).
Required/Preferred Skills:
- High-quality written/oral communication; strong negotiation and project management.
- Ability to collaborate in a remote cross-functional environment; prioritize multiple activities and adapt to shifting priorities.
- PC literacy; MS Office (Outlook, Word, Excel, PowerPoint).
- In-depth knowledge of FDA/EU regulations, ICH, and GCP.
Travel: Up to 30%.
Benefits (if offered): annual performance incentive bonus, new hire equity, ongoing performance-based equity; medical/dental/vision insurance, 401k match, unlimited PTO, paid holidays including winter shutdown.