Job description

Clinical Project Manager II (Non-MD)

**Remember – this manager wants to see DIRECT clinical supplies management experience. He will pass if that experience doesn’t show on resume and in previous roles held**

Education Requirement:

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

Experience:

• 5+ 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 overages

Critical Success Factors:

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

Job Type: Contract

Salary: $60.00 - $70.00 per hour

Schedule:

• 8 hour shift
• Day shift

Ability to commute/relocate:

• North Chicago, IL 60064: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Clinical Supplies: 5 years (Preferred)
• Supply chain: 5 years (Preferred)
• pharma industry: 5 years (Preferred)
• Project Management: 5 years (Preferred)
• drug development: 5 years (Preferred)

Work Location: One location

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