Clinical Supplies Project Manager in North Chicago, IL

Hybrid – Lake County - The individuals are expected to work onsite Tuesday – Thursday each week. Mondays and Fridays have flexibility

• 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.
• 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.
• Clinical Project manager with Pharma exp will work
• Quality Assurance individual with Pharma exp will also work

Education Requirement:

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

Experience:

• 2+ years total experience in the Pharmaceutical Industry.
• Preferably experience in one of the following areas:
• Drug discovery (eg, Process Chemistry, Analytical Chemistry)
• Drug development (eg, Formulation)
• Clinical operations (eg, Clinical Project Management)
• Supply chain (eg, Clinical Supplies Project Management)
• Quality Assurance

Major Responsibilities:

• Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and Phase I – IV clinical trials
• 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 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 overages.

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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