Senior Clinical Trial Lead — Global Phase 3 (Hybrid Boston)

Regulatory Jobs; Boston (MA); On-site; USD 165,000 - 185,000; Full time

Benefits offered by this job

Unlimited PTO

Lifestyle spending account

Commuting reimbursement

Job summary

Rapport Therapeutics in Boston is seeking an experienced Clinical Operations Lead to drive a global Phase 1–III program across sites. You will partner with the COL to ensure study start-up, monitoring, and close-out with rigorous GCP and ICH adherence.

You'll oversee CTMS/eTMF workflows, vendor management, and trial documentation while coordinating cross-functional teams and communicating updates to stakeholders. Onsite schedule is Mon-Wed at our Boston office.

Qualifications

• 6–8 years of clinical operations experience in biotech or pharma.
• Solid understanding of GCP, ICH guidelines and the clinical development process.
• Experience with CTMS and eTMF systems.

Responsibilities

• Provide support to the Clinical Operations Lead in planning, execution, and oversight of a global Phase 3 trial from start-up to close-out.
• Develop, review, and track study-related documents with cross-functional teams.
• Oversee start-up activities to accelerate country and site activations.
• Oversee CROs and vendors, monitor performance, and ensure high-quality deliverables.
• Track timelines, enrollment, deviations, data trends, and sample management with CRO and internal stakeholders.
• Maintain trial documentation and ensure inspection readiness.
• Contribute to inspection readiness and ensure compliance with GCP and SOPs.
• Identify and resolve site risks and foster positive site relationships.
• Coordinate internal meetings and cross-functional study meetings.

Skills

Clinical operations experience

GCP & ICH knowledge

Cross-functional collaboration

Documentation & compliance

Education

Bachelor’s degree in life sciences or healthcare

Tools

CTMS

eTMF

Job description

Rapport Therapeutics in Boston is seeking an experienced Clinical Operations Lead to drive a global Phase 1–III program across sites. You will partner with the COL to ensure study start-up, monitoring, and close-out with rigorous GCP and ICH adherence.

You'll oversee CTMS/eTMF workflows, vendor management, and trial documentation while coordinating cross-functional teams and communicating updates to stakeholders. Onsite schedule is Mon-Wed at our Boston office.