Clinical Supply Project Manager II

job summary:
The Clinical Project Manager II (CPM II) serves as a strategic lead for the end-to-end management of clinical supply chain activities across Phase I through IV and Investigator-Initiated Studies (IIS). This role is instrumental in translating complex clinical study designs into executable packaging and distribution strategies, ensuring the seamless availability of investigational drug supplies to global clinical sites. By integrating scientific rigor with operational excellence, the CPM II mitigates risk and optimizes resources to support the delivery of life-changing therapeutic modalities.

location: North Chicago, Illinois
job type: Contract
salary: $65.00 - 72.61 per hour
work hours: 9 to 5
education: Bachelors


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

qualifications:

Required Qualifications

• Education: Bachelor's Degree required, preferably in physical or biological sciences, mathematics, engineering, or pharmacy.
• Experience: A minimum of 5 years of dedicated clinical supplies project management experience within the Pharmaceutical or Biotechnology industry.
• Technical Proficiency: Demonstrated expertise in clinical development cycles and the global regulatory landscape governing investigational product supply.
• Operational Excellence: Proven ability to manage complex, multi-functional projects and prioritize tasks in a high-pressure, regulated environment.

Preferred Qualifications

• Advanced Logistics: Experience managing complex Phase III global distribution networks.
• Systems Knowledge: Proficiency with IRT/IXRS platforms and advanced supply forecasting tools.
• Collaborative Leadership: Strong track record of effectively interfacing with Clinical, QA, and Analytical departments to drive project milestones.

#LI-AO1

skills: Project Management, Phase I, Phase II, Phase iii, Phase iv, MS-Project, Investigator-Initiated Study (IIS), International Council for Harmonization (ICH)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.