Senior Clinical Project Manager

The role

The Senior Clinical Project Manager leads the planning, execution, oversight, and delivery of domestic and global postmarketing clinical trials. This role serves as an operational leader partnering cross-functionally to ensure trials meet timelines, budgets, and regulatory standards.

What you will do

• Lead operational execution of domestic or global multi-center late phase clinical trials.
• Oversee vendors and CROs to ensure accountability and quality.
• Develop and manage study timelines, contract/budget negotiations, and risk mitigation plans.
• Initiate and manage request for proposal activities for clinical studies or vendors.
• Lead cross-functional study execution teams.
• Manage clinical development vendors according to oversight plans.
• Oversee study-level data monitoring activities and conduct Sponsor oversight monitoring visits.
• Perform monthly Protocol Deviation review and collaborate with Medical Monitor.
• Prepare and review study-related plans, documents, and site study documents.
• Assist in strategic trial design and protocol writing.

Required qualifications

• Bachelor's degree in Life Sciences or a related scientific discipline
• 8+ years of Clinical Trial / Project Management experience within CRO, biotechnology or pharmaceutical organizations
• Demonstrated experience operating at a Senior Clinical Trial Lead or Associate Director level
• Proven leadership of global clinical studies and cross-functional project teams
• Strong experience managing CROs, vendors, and external partners
• Extensive knowledge of ICH-GCP, FDA, EMA, and global clinical trial regulations
• Excellent communication, leadership, and project management skills

Nice to have

• Advanced degree
• 5+ years’ experience of clinical trial management for late phase studies
• Experience with IMP/clinical drug supply logistics, planning, and labeling activities in late phase studies
• Effective communicator who can manage multiple priorities while building strong internal relationships across multiple departments

About the company

Azurity Pharmaceuticals is an inclusive workplace and an Equal Opportunity Employer. The company focuses on repurposing proven molecules and reimagining how therapies are designed, delivered, and accessed.