Global Clinical Trial Lead

Prelude-Therapeutics-Incorporated; Wilmington (DE); On-site; USD 120,000 - 180,000; Full time

Job summary

Prelude Therapeutics Incorporated seeks a Clinical Trial Manager to lead operational activities for multiple assets within its pipeline. You will ensure deliverables meet timelines, budgets, SOPs, and quality standards while coordinating with internal teams and external vendors.

The role requires extensive experience in clinical operations, oncology trials, and global trial management, with strong leadership and communication skills to mentor staff and manage remote teams.

Qualifications

• Bachelor’s degree required.
• 3–5 years direct clinical study management experience.
• 7–10 years of clinical operations management experience in pharma, CRO, or investigator site setting.
• Experience managing oncology or complex clinical trials.
• Global clinical trial experience across multiple programs.
• Strong working knowledge of ICH/GCP.
• Experience with EDC, CTMS, TMFs and regulatory documents.
• Experience overseeing CROs/vendors and vendor contract review.
• Excellent communication skills and ability to mentor staff; capable of leading remote teams.
• Self-motivated with ability to handle shifting priorities.

Responsibilities

• Lead one or more clinical trials and manage day-to-day operational aspects and study teams.
• Foster cross-functional collaboration to meet timelines and quality standards.
• Oversee CRO performance and vendor relationships.
• Establish and maintain study timelines and trial progress tracking.
• Provide input on enrollment forecasting, supply management, and data review.
• Assist with regulatory submissions and site inspection readiness as needed.
• Travel 10–20% depending on project needs.

Skills

Clinical study management

Vendor management

CRO oversight

Regulatory knowledge (ICH/GCP)

EDC/CTMS/TMF systems

Project management

Leadership & mentoring

Budget management

Remote team management

Communication skills

Education

Bachelor’s degree

Tools

EDC

CTMS

TMF systems

Microsoft Office

Project

Job description

Prelude Therapeutics Incorporated seeks a Clinical Trial Manager to lead operational activities for multiple assets within its pipeline. You will ensure deliverables meet timelines, budgets, SOPs, and quality standards while coordinating with internal teams and external vendors.

The role requires extensive experience in clinical operations, oncology trials, and global trial management, with strong leadership and communication skills to mentor staff and manage remote teams.