Clinical Supply Chain Manager

Job Title:

Clinical Supply Chain Manager Length of assignment: 12-month contract with potential to extend

Location:

Waukegan Road, North Chicago, IL 60064 What we are looking for: Minimum 5+ years of experience managing clinical trial supplies or clinical supply chain operations in the pharmaceutical or biotech industry. Hands-on experience supporting Phase I-IV clinical trials. Must understand protocol-level supply planning. Project Management Experience including Experience managing clinical supply timelines, milestones, and logistics. Ability to track protocol-level supply activities and risks. Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy. Candidate experience with Investigational drug forecasting, Clinical supply planning, Distribution to clinical sites and depots, and managing study medication availability will be prioritized. Experience translating clinical study protocols into packaging and labeling requirements. Packaging and Labeling for Clinical Trials. Knowledge of global clinical labeling regulations is desired.

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).