Clinical Project Manager - Remote

Description:

• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
• This includes forecasting, planning, scheduling, coordination, and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
• Authors the study medication and labeling section of the clinical protocol.
• Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning.
• Identifies, develops, communicates, and tracks project timelines, activities, logistics, and milestones.
• Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity.
• Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies, and commodities, including overages.
• Translates clinical study design into packaging design.
• Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
• Develops protocol specific labeling compliant with applicable global regulations.

Qualifications:

• Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work
• Good communication skills (both written and oral
• Project Management skills
• Understanding of clinical development and global supply chain requirements
• Competent in the application of standard business requirements (for example SOPs, Global Regulations)
• 5+ years clinical supplies project management experience in the Pharmaceutical Industry
• Ability to manage and prioritize multiple tasks
• Bachelor’s Degree required preferably in physical/biological science, math, engineering, or pharmacy
• Ability to work effectively and professionally with those in the dept: Clinical, QA, Analytical and any area interface
• Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional, and effective manner