Global Late-Phase Clinical Project Lead

Azurity Pharmaceuticals - US; Woburn (MA); Hybrid; USD 130,000 - 185,000; Full time

Job summary

Azurity Pharmaceuticals - US is seeking a Senior Clinical Project Manager to lead planning, execution, and delivery of domestic and global late-phase trials. You will partner with Regulatory, Medical, Drug Safety, Data Management, and CRO vendors to ensure trials meet timelines, quality standards, and budget expectations.

The role requires 8+ years in clinical trial management, strong leadership, and deep knowledge of ICH-GCP and regulatory requirements.

Qualifications

• 8+ years of Clinical Trial / Project Management experience.
• Experience at Senior Clinical Trial Lead or Associate Director level.
• Proven leadership of global clinical studies and cross-functional teams.
• Experience managing CROs, vendors, and external partners.
• Extensive knowledge of ICH-GCP, FDA, EMA and global trial regulations.
• Excellent communication and leadership skills.

Responsibilities

• Lead domestic or global late-phase clinical trials and manage CROs/vendors to ensure on-time, within-budget delivery.
• Develop and manage study timelines, budgets, and risk mitigation plans.
• Oversee study documentation, TMF readiness, and regulatory/compliance processes.
• Coordinate cross-functional study teams across Regulatory, Drug Safety, Medical, and Data Management.
• Support strategic trial design, protocol writing, and site/country selection.

Skills

Senior leadership

Project management

Vendor management

Cross-functional leadership

Communication

ICH-GCP knowledge

Regulatory knowledge

Global study leadership

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Tools

FDA/EMA regulatory knowledge

Job description

Azurity Pharmaceuticals - US is seeking a Senior Clinical Project Manager to lead planning, execution, and delivery of domestic and global late-phase trials. You will partner with Regulatory, Medical, Drug Safety, Data Management, and CRO vendors to ensure trials meet timelines, quality standards, and budget expectations.

The role requires 8+ years in clinical trial management, strong leadership, and deep knowledge of ICH-GCP and regulatory requirements.