Senior Clinical Project Manager

The role

The Senior Clinical Project Manager leads the planning, execution, oversight, and delivery of domestic and/or global postmarketing required clinical trials. This role serves as the operational leader for assigned studies, partnering cross-functionally to ensure delivery on time, within budget, and in compliance with regulations.

What you will do

• Lead operational execution of domestic or global multi-center late phase clinical trials
• Oversee selected vendors and CROs for 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 study execution team comprised of cross-functional representatives
• Manage clinical development vendors according to vendor 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 study plans 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 has more than 70 medicines across 11 therapeutic areas reaching millions of people in more than 50 countries.