Clinical Supply Chain Project Manager

Collabera is seeking a Clinical Project Manager II to oversee clinical supply chain activities for various clinical studies. This role involves managing the forecasting, planning, and delivery of investigational drug supplies while ensuring compliance with regulatory requirements and collaborating with cross-functional teams.

Responsibilities:

• Manage clinical supply chain activities at the protocol level for Phase 1, Phase 2, Phase 3, Phase 4, and investigator-initiated clinical studies
• Forecast, plan, schedule, coordinate, and execute supply chain activities to ensure timely availability of investigational drug supplies
• Collaborate with clinical study teams to provide input on protocol design and optimize the utilization of supply chain resources
• Translate clinical study design into packaging strategies and supply requirements
• Author the study medication and labeling sections of clinical protocols
• Develop protocol-specific labeling that complies with applicable global regulatory requirements
• Identify and track project timelines, milestones, logistics, and key activities for clinical supply operations
• Coordinate manufacturing and packaging work orders with third-party vendors, interactive response technology vendors, quality teams, and clinical partners
• Conduct supply scenario analysis and implement risk management and contingency planning strategies
• Forecast bulk drug product requirements including comparator agents, ancillary supplies, and required overages
• Ensure compliance with standard operating procedures and global regulatory requirements within a regulated environment
• Collaborate effectively with cross-functional teams including clinical operations, quality, analytical, and other operational partners

Requirements:

• Bachelor's degree in physical science, biological science, mathematics, engineering, pharmacy, or a related scientific discipline
• Experience managing clinical supply chain or clinical supply project management activities within the pharmaceutical industry
• Strong understanding of clinical development processes and global clinical supply chain requirements
• Knowledge of regulatory compliance and standard operating procedures within a regulated environment
• Strong project management skills with the ability to manage multiple priorities simultaneously
• Excellent written and verbal communication skills
• Experience supporting complex clinical trials across multiple phases
• Experience collaborating with cross-functional teams including clinical operations, quality, and analytical functions
• Experience working with third-party vendors and supply logistics partners