Global Late-Phase Clinical Project Lead

Regulatory Jobs; Woburn (MA); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Healthcare

401(k) match

Bonus potential

Job summary

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, and delivery of domestic and global late-phase trials. You will partner with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are delivered on time, within budget, and in compliance with ICH-GCP and applicable regulations.

You will oversee timelines, budgets, CRO relationships, and cross-functional study teams, driving study excellence and

Qualifications

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

Responsibilities

• Lead operational execution of domestic/global late-phase trials, overseeing vendor/CRO performance.
• Develop and manage study timelines, budgets, and risk mitigation plans.
• Initiate RFP activities for studies and vendors, including CROs and labs.
• Lead cross-functional study execution teams to ensure study excellence.
• Manage clinical development vendors per oversight plans.
• Oversee data monitoring activities and sponsor oversight visits.
• Coordinate study plans and TMF/documentation readiness.
• Assist in trial design and protocol development.

Skills

Leadership

Communication

Project management

Vendor management

ICH-GCP expertise

Regulatory knowledge

Budget management

Education

Bachelor's in Life Sciences

Job description

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, and delivery of domestic and global late-phase trials. You will partner with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are delivered on time, within budget, and in compliance with ICH-GCP and applicable regulations.

You will oversee timelines, budgets, CRO relationships, and cross-functional study teams, driving study excellence and