James McMonagle
Senior Specialist, Project Management, P&L
- Role
- Senior Specialist, Project Management, Packaging and Labeling at Bristol Myers Squibb
- Location
- Philadelphia, PA, US
- LinkedIn followers
- 500 followers
About James McMonagle
Systems-oriented project manager and clinical supply professional with a strong background in process development and global clinical trial support. Experienced in end-to-end clinical supply execution, including packaging and labeling operations, SAP order management, and documentation supporting regulatory release. Known for improving efficiency, building scalable processes, and maintaining delivery reliability across multiple concurrent studies.
Experience
Senior Specialist, Project Management, Packaging and Labeling
Jan 2026 — Present · New Brunswick, NJ, US
Lead project management activities supporting clinical supply packaging and labeling operations in alignment with clinical trial designs and regulatory requirements- Manage multiple concurrent projects, developing and maintaining detailed timelines, milestones, and production schedules to ensure on-time delivery of clinical supplies- Coordinate availability of clinical deliverables including drug product, packaging components, label text, and randomization materials from single to triple-blind- Oversee creation, review, and release of production orders, labeling specifications, and Bills of Materials- Partner cross-functionally with Trial Supply Management, Quality Assurance, Manufacturing, and external vendors to support compliant execution and release of finished supplies- Compile and review supporting documentation and batch records to enable quality review and clinical release
Education
University of Pittsburgh
Bachelor of Science (BS), Emergency Medicine
2009 — 2014
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