Senior Clinical Project Lead - Global Late-Phase (Hybrid)

Azurity Pharmaceuticals; Raleigh (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

401K retirement plan

Annual bonus program

Tuition reimbursement

Paid time off

Job summary

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, and delivery of late-phase trials domestically and globally. You will coordinate cross-functional teams and external vendors to ensure on-time, on-budget trials compliant with ICH-GCP.

The role requires strong leadership, extensive CRO/vendor management experience, and a strategic mindset to drive trial design, protocol development, and regulatory readiness across multiple

Qualifications

• Bachelor's degree in Life Sciences or related field (advanced degree preferred).
• 8+ years in Clinical Trial/Project Management within CRO/biotech/pharma.
• Experience at Senior Clinical Trial Lead or Associate Director level.
• Proven leadership of global clinical studies with cross-functional teams.
• Strong CRO/vendor management and regulatory knowledge (ICH-GCP, FDA/EMA).
• Excellent communication and leadership skills.

Responsibilities

• Lead operational execution of late-phase trials with CRO oversight.
• Develop study timelines, budgets, and risk mitigation plans.
• Initiate and manage RFP activities for studies and vendors.
• Lead cross-functional study execution team across Regulatory, Data, Quality.
• Manage clinical development vendors and ensure study excellence.
• Ensure regulatory compliance, TMF readiness, and audits.
• Plan country/site selection with program input.

Skills

Leadership

Cross-functional collaboration

Communication

Project management

ICH-GCP knowledge

Vendor management

Education

Bachelor's degree in Life Sciences or related field

Job description

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, and delivery of late-phase trials domestically and globally. You will coordinate cross-functional teams and external vendors to ensure on-time, on-budget trials compliant with ICH-GCP.

The role requires strong leadership, extensive CRO/vendor management experience, and a strategic mindset to drive trial design, protocol development, and regulatory readiness across multiple