Senior Clinical Project Manager — Global Trials Lead (Hybrid)

Regulatory Jobs; Raleigh (NC); On-site; USD 130,000 - 165,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead the planning and delivery of domestic and global postmarketing trials. You will partner with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are on time, within budget, and compliant with ICH-GCP.

The role requires 8+ years in clinical trial management, global study leadership, and strong CRO/vendor oversight.

Qualifications

• 8+ years of Clinical Trial / Project Management experience.
• Experience leading senior/Associate Director level studies.
• Proven success managing CROs and external partners.
• Strong knowledge of ICH-GCP, FDA/EMA regulations.
• Excellent communication and leadership abilities.

Responsibilities

• Lead the operational execution of late-phase trials and oversee CROs.
• Develop study timelines, budgets, and risk mitigation plans.
• Initiate and manage vendor RFP activities for studies.
• Lead cross-functional study teams to oversee CROs and ensure study excellence.
• Oversee vendor management and ensure study quality.
• Ensure study documentation and QA readiness per regulations.

Skills

Senior leadership

Global trial management

Vendor management

ICH-GCP knowledge

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Life Sciences

Advanced degree preferred

Job description

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead the planning and delivery of domestic and global postmarketing trials. You will partner with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are on time, within budget, and compliant with ICH-GCP.

The role requires 8+ years in clinical trial management, global study leadership, and strong CRO/vendor oversight.