Senior Clinical Trial Manager
Stoke Therapeutics
August 12, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Position Purpose:
Sr. Clinical Trial Manager (Sr. CTM) serves as Global Study Lead in an outsourced model, providing oversight to CROs/vendors and managing study start-up and execution to ensure vendor/system and cross-functional integration from protocol concept through clinical study report.
Key Responsibilities:
- Lead cross-functional clinical study team; oversee all aspects of assigned studies per protocol, GCP, timelines, and budget (CDP).
- Lead study feasibility, select sites/countries, and ensure timely site activation.
- Oversee vendor qualification/selection and correct vendor set-up; ensure UATs are completed where needed.
- Provide input into protocols, informed consent forms (ICFs), and related documents.
- Develop and oversee study operational plans; maintain compliance and quality.
- Manage study timelines vs. CDP and align with internal stakeholders.
- Proactively identify risks/issues, coordinate mitigations with study team/CRO/vendors, and escalate as needed.
- Provide vendor/CRO oversight to ensure protocol and GCP compliance.
- Coordinate timely study status updates with internal stakeholders.
- Coordinate with CMC on drug forecasting and site supply.
- Support databases lock (including interim locks) via monitoring plans and data review/reconciliation.
- Support clinical budgeting inputs and forecasts.
- Participate in scenario planning (timelines/costs) and drive clinical operations performance.
- Ensure Trial Master File (TMF) inspection readiness; provide/review study dashboards.
Required/Preferred Skills & Experience:
- Bachelor’s+ in scientific/healthcare discipline (preferred).
- 8+ years leading global pivotal trials in biotech/pharma/CRO (Sr. CTM).
- Oversight experience with CROs/vendors delivering on time, quality, budget.
- Oversight review experience of PSVs, SIVs, IMVs, COVs.
- Pediatric rare disease and neurology experience highly desirable.
- Strong ICH-GCP and drug development process knowledge.
- Proficient in Word/Excel/Outlook/PowerPoint/MS Project.
- Excellent communication; independent and collaborative in fast-paced start-up.
Application Instructions:
Apply via Stoke Therapeutics Career Center: https://www.stoketherapeutics.com/careers/.
Sr. Clinical Trial Manager (Sr. CTM) serves as Global Study Lead in an outsourced model, providing oversight to CROs/vendors and managing study start-up and execution to ensure vendor/system and cross-functional integration from protocol concept through clinical study report.
Key Responsibilities:
- Lead cross-functional clinical study team; oversee all aspects of assigned studies per protocol, GCP, timelines, and budget (CDP).
- Lead study feasibility, select sites/countries, and ensure timely site activation.
- Oversee vendor qualification/selection and correct vendor set-up; ensure UATs are completed where needed.
- Provide input into protocols, informed consent forms (ICFs), and related documents.
- Develop and oversee study operational plans; maintain compliance and quality.
- Manage study timelines vs. CDP and align with internal stakeholders.
- Proactively identify risks/issues, coordinate mitigations with study team/CRO/vendors, and escalate as needed.
- Provide vendor/CRO oversight to ensure protocol and GCP compliance.
- Coordinate timely study status updates with internal stakeholders.
- Coordinate with CMC on drug forecasting and site supply.
- Support databases lock (including interim locks) via monitoring plans and data review/reconciliation.
- Support clinical budgeting inputs and forecasts.
- Participate in scenario planning (timelines/costs) and drive clinical operations performance.
- Ensure Trial Master File (TMF) inspection readiness; provide/review study dashboards.
Required/Preferred Skills & Experience:
- Bachelor’s+ in scientific/healthcare discipline (preferred).
- 8+ years leading global pivotal trials in biotech/pharma/CRO (Sr. CTM).
- Oversight experience with CROs/vendors delivering on time, quality, budget.
- Oversight review experience of PSVs, SIVs, IMVs, COVs.
- Pediatric rare disease and neurology experience highly desirable.
- Strong ICH-GCP and drug development process knowledge.
- Proficient in Word/Excel/Outlook/PowerPoint/MS Project.
- Excellent communication; independent and collaborative in fast-paced start-up.
Application Instructions:
Apply via Stoke Therapeutics Career Center: https://www.stoketherapeutics.com/careers/.