Senior Clinical Operations Study Lead

Dyne Therapeutics; Waltham (MA); On-site; USD 165,000 - 200,000; Full time

Job summary

Dyne Therapeutics in Waltham, MA is seeking a Clinical Operations Study Lead to translate clinical strategies into actionable trials across all phases. You will oversee CROs and vendors, align operational execution with project priorities, timing, budget, and quality requirements.

The role requires 8+ years in clinical trial management, strong leadership, and travel up to 20%. You will ensure ICH GCP compliance and manage study budgets, risk assessments and TMF readiness while supporting site

Qualifications

• 8+ years of clinical trial management experience in Phase I-III trials.
• Experience with sponsor and CRO environments, budgets, timelines and quality.
• Experience in neuromuscular or rare/pediatric trials preferred.
• Strong knowledge of ICH GCP and privacy laws.
• Ability to lead cross-functional teams and travel as needed.
• Experience with vendor selection and CRO oversight.

Responsibilities

• Oversee end-to-end clinical operations from start-up to close-out
• Develop study-level operational strategy aligned with CDP
• Manage budgets, invoices, and forecasting for studies
• Oversee CROs and vendors ensuring KPIs and quality
• Ensure study documentation and TMF inspection readiness
• Lead cross-functional study teams with CRO partners
• Engage sites and KOLs to support enrollment
• Coordinate patient enrollment strategies with CRO
• Monitor data quality and drive issue mitigation
• Prepare senior-management reports on program status

Skills

Clinical trial management

Cross-functional leadership

Regulatory compliance

Vendor management

Budget forecasting

Communication skills

Education

Undergraduate degree in science/health

Advanced degree desirable

Job description

Dyne Therapeutics in Waltham, MA is seeking a Clinical Operations Study Lead to translate clinical strategies into actionable trials across all phases. You will oversee CROs and vendors, align operational execution with project priorities, timing, budget, and quality requirements.

The role requires 8+ years in clinical trial management, strong leadership, and travel up to 20%. You will ensure ICH GCP compliance and manage study budgets, risk assessments and TMF readiness while supporting site