Global Senior CTM – Pediatric Rare Disease Trials (Remote)

Stoke Therapeutics; Cambridge (MA); Hybrid; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Stoke Therapeutics is seeking a Sr. Clinical Trial Manager to serve as a Global Study Lead, providing oversight to CROs and vendors from protocol concept through study report. The role focuses on study startup, execution, risk management, and cross-functional coordination to ensure quality deliverables.

Location is in Bedford/Waltham, MA with a remote/hybrid work model and approximately 15% travel. Pediatric rare disease and neurology experience are highly desirable, with flexibility to adapt to

Qualifikationen

• Bachelor’s degree in a scientific or healthcare discipline.
• 8+ years of progressive experience leading global pivotal clinical trials.
• Experience in overseeing CROs and vendors delivering on time and within budget.
• Pediatric rare disease and Neurology experience is desirable.
• Strong knowledge of ICH-GCP guidelines and Drug Development process.
• Proficiency with MS Office tools and project management software.

Aufgaben

• Lead a cross-functional clinical study team with CRO/vendor oversight and ensure studies adhere to protocol, GCP, timelines, and budget.
• Oversee site feasibility, selection, and activation across sites/countries.
• Oversee vendor qualification and setup, including user acceptance testing as needed.
• Contribute to study protocols, ICFs, and other study documents.
• Develop and maintain study operational plans and timelines per the CDP.
• Identify and mitigate study risks with the team, CRO, and vendors.
• Ensure TMF readiness and participate in data review and reconciliation.
• Support budgeting, accruals, and forecast updates with finance.
• Maintain study dashboards and contribute to SOP development.

Kenntnisse

CRO oversight

Global study leadership

ICH-GCP knowledge

Communication skills

Independent work

Budgeting & planning

Ausbildung

Bachelor’s degree in science

Tools

MS Word

MS Excel

MS Project

Jobbeschreibung

Stoke Therapeutics is seeking a Sr. Clinical Trial Manager to serve as a Global Study Lead, providing oversight to CROs and vendors from protocol concept through study report. The role focuses on study startup, execution, risk management, and cross-functional coordination to ensure quality deliverables.

Location is in Bedford/Waltham, MA with a remote/hybrid work model and approximately 15% travel. Pediatric rare disease and neurology experience are highly desirable, with flexibility to adapt to