Senior Clinical Program Lead, Late-Phase Trials

Azurity Pharmaceuticals; Woburn (MA); On-site; USD 140,000 - 190,000; Full time

Job summary

Azurity Pharmaceuticals is seeking a Senior Clinical Project Manager, Clinical Development to lead planning, execution, and delivery of domestic and/or global postmarketing trials. You will serve as the operational leader, partnering with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are delivered on time and within budget.

This role requires 8+ years in clinical trial management within CRO/pharma, strong CRO/vendor management, and deep knowledge of

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 8+ years of clinical trial/project management in CRO/pharma.
• Proven leadership of global 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 and project management skills.

Responsibilities

• Lead operational execution of late-phase trials and oversee CROs to ensure quality and on-time delivery.
• Develop and manage study timelines, budgets, and risk mitigation plans.
• Coordinate RFP activities for clinical studies and vendors.
• Lead cross-functional study teams across Regulatory, Safety, Medical, Data Management, and Quality.
• Ensure compliance with ICH-GCP, FDA, EMA and SOPs; manage TMF submissions and audits.
• Support study design and protocol development and strategic site/country selection.

Skills

Leadership

Cross-functional collaboration

Budget/Contract management

Vendor management

ICH-GCP knowledge

Communication

Education

Bachelor's degree 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/or global postmarketing trials. You will serve as the operational leader, partnering with Medical, Regulatory, Data Management, Quality, and external vendors to ensure trials are delivered on time and within budget.

This role requires 8+ years in clinical trial management within CRO/pharma, strong CRO/vendor management, and deep knowledge of