Senior Global CTM – CRO & Study Leadership

Regulatory Jobs; Bedford (MA); Hybrid; USD 140,000 - 220,000; Full time

Job summary

Stoke Therapeutics is seeking a Sr. Clinical Trial Manager to oversee global pivotal trials in a mostly remote, with limited on-site work arrangement in Bedford, MA. The role focuses on study startup, execution, and vendor coordination across CROs and vendors within an outsourced model.

The candidate should bring 8+ years in global trials, with pediatric rare disease or neurology exposure preferred, and strong GCP/regulatory knowledge to drive trial success.

Qualifications

• Bachelor’s degree or higher in a scientific or healthcare discipline.
• Minimum of 8 years leading global pivotal clinical trials.
• Experience overseeing CROs and vendors, delivering on time and budget.
• Experience reviewing PSVs, SIVs, IMVs, and COVs.
• Pediatric rare disease and neurology study experience is desirable.

Responsibilities

• Lead a cross-functional study team and oversee CROs and vendors to ensure studies meet protocol, GCP, timelines and budget.
• Oversee site selection, activation, and feasibility to ensure timely study start.
• Lead vendor/partner qualification, setup, and where needed UATs.
• Contribute to study protocols, ICFs, and essential study documents.
• Develop and monitor operational plans to ensure quality and compliance.
• Identify and mitigate study risks with the team, CRO, and vendors.

Skills

CRO Oversight

Global Study Lead

Vendor Management

GCP Knowledge

Pediatric Rare Disease

Education

Bachelor’s degree in science/healthcare

Tools

MS Project

Microsoft Office

Job description

Stoke Therapeutics is seeking a Sr. Clinical Trial Manager to oversee global pivotal trials in a mostly remote, with limited on-site work arrangement in Bedford, MA. The role focuses on study startup, execution, and vendor coordination across CROs and vendors within an outsourced model.

The candidate should bring 8+ years in global trials, with pediatric rare disease or neurology exposure preferred, and strong GCP/regulatory knowledge to drive trial success.