Senior Clinical Trial Manager
Verastem Oncology
August 14, 2026
Remote friendly (Boston, MA)
United States
Clinical Research and Development
Responsibilities:
- Serve as primary liaison between clinical vendors (CRO, IRT, eTMF) and Verastem Oncology; ensure understanding of expectations/scope, quality, and budget; manage SOW changes and accruals.
- Manage assigned global Phase 3 clinical trials to ensure efficient, on-time, within-budget execution per SOPs and applicable regulations.
- Oversee the full project lifecycle (set-up to close), including vendor performance, internal metrics, QA checks, and trial status communication.
- Support RFPs: distribute to vendors, review proposals, coordinate bid defenses, and help select vendors to maximize savings.
- Negotiate master service agreements, work orders, contracts, and amendments for sites/vendors.
- Assist with study-specific feasibility and site selection.
- Author/review clinical documents (protocols, informed consent forms, CRF design/guidelines, and related materials).
- Coordinate with medical monitor and cross-functional teams to produce study deliverables (e.g., project, data, safety, monitoring plans; pharmacy/lab manuals; clinical study reports).
- Partner with Data Management on data cleaning and review of metrics/patient profiles.
- Address issues/risks and develop mitigation plans; oversee monitoring activities (review reports, deviations, CAPAs; attend co-monitoring).
- Chair study team meetings and maintain minutes/action items.
- Maintain trial master file and ensure audit readiness.
- Ensure corrective actions are implemented and may participate in audits.
- Update tracking spreadsheets; forecast and reconcile budgets with Finance; create/update clinical SOPs with Quality Assurance.
Qualifications:
- Global Phase 3 clinical trial management experience.
- 5–7+ years of clinical trial experience, including oncology; BA/BS (or equivalent) in a scientific/healthcare field.
- Strong understanding of ICH, GCP, and applicable regulatory guidelines.
- Excellent written/verbal communication; ability to prioritize and multi-task; travel may be required.
Compensation/Benefits:
- Base salary range: $130K–$150K; bonus, equity compensation, and competitive benefits package.
- Serve as primary liaison between clinical vendors (CRO, IRT, eTMF) and Verastem Oncology; ensure understanding of expectations/scope, quality, and budget; manage SOW changes and accruals.
- Manage assigned global Phase 3 clinical trials to ensure efficient, on-time, within-budget execution per SOPs and applicable regulations.
- Oversee the full project lifecycle (set-up to close), including vendor performance, internal metrics, QA checks, and trial status communication.
- Support RFPs: distribute to vendors, review proposals, coordinate bid defenses, and help select vendors to maximize savings.
- Negotiate master service agreements, work orders, contracts, and amendments for sites/vendors.
- Assist with study-specific feasibility and site selection.
- Author/review clinical documents (protocols, informed consent forms, CRF design/guidelines, and related materials).
- Coordinate with medical monitor and cross-functional teams to produce study deliverables (e.g., project, data, safety, monitoring plans; pharmacy/lab manuals; clinical study reports).
- Partner with Data Management on data cleaning and review of metrics/patient profiles.
- Address issues/risks and develop mitigation plans; oversee monitoring activities (review reports, deviations, CAPAs; attend co-monitoring).
- Chair study team meetings and maintain minutes/action items.
- Maintain trial master file and ensure audit readiness.
- Ensure corrective actions are implemented and may participate in audits.
- Update tracking spreadsheets; forecast and reconcile budgets with Finance; create/update clinical SOPs with Quality Assurance.
Qualifications:
- Global Phase 3 clinical trial management experience.
- 5–7+ years of clinical trial experience, including oncology; BA/BS (or equivalent) in a scientific/healthcare field.
- Strong understanding of ICH, GCP, and applicable regulatory guidelines.
- Excellent written/verbal communication; ability to prioritize and multi-task; travel may be required.
Compensation/Benefits:
- Base salary range: $130K–$150K; bonus, equity compensation, and competitive benefits package.