Clinical Supplies Project Manager in North Chicago, IL

Clinical Project Manager II (Non-MD)

• 10 plus yrs of exp will be considered.
• Scientific background needed.
• IRT exp
• Supply Chain background will work..
• Someone with drug discovery background will work.
• Involved in clinical protocol in first 6 - 9 months of clinical study.
• 3yrs exp needed.
• Clinical supplies PM exp
• Will work in R&D specially with development sciences.
• US, local and global studies involved.
• Pharma industry exp will work.
• Quality Assurance background will work
• Training involved: 6 - 8-week training.
• Business side degree will not be a good fit.
• Project management exp needed.

• Bachelor’s Degree required preferably in physical/biological science, math, engineering or pharmacy.

Experience: 

• 3+ years clinical supplies project management experience in the Pharmaceutical Industry.

Major Responsibilities:

• 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
• Includes forecasting, planning, scheduling, coordination and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots. 
• Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
• Translates clinical study design into packaging design. Authors the study medication and labeling section of the clinical protocol.
• Develops protocol specific labeling compliant with applicable global regulations.
• Identifies, develops, communicates and tracks project timelines, activities, logistics, and milestones.
• 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.
• Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning. Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies and commodities, including overage

Critical Success Factors:

• Understanding of clinical development and global supply chain requirements.
• Competent in the application of standard business requirements (for example SOPs, Global Regulations).
• Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work.
• Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional and effective manner.
• Ability to work effectively and professionally with those in the dept as well as Clinical, QA, Analytical and any area interface.
• Ability to manage and prioritize multiple tasks.
• Project Management skills.
• Good communication skills (both written and oral).

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