Project Manager, Clinical Supply

AbbVie•North Chicago, IL

18h

About The Position

Forecasts, plans, schedules, coordinates and executes, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots for clinical supply chain activities. This position is the entry-level position for the GDSM Project Management function. Works on the less complex clinical studies and will require significant guidance through the learning curve process.

Requirements

Bachelor’s degree in the Life or Physical Sciences preferred. Will consider Business Administration, Math or Engineering with appropriate work experience.
1 year of project management experience or 3+ total years of Pharmaceutical or Biotechnology industry or equivalent experience preferred.
Must have excellent problem solving and logical reasoning skills.
Proactive approach to problem solving, thinking outside of the box, and ability to identify creative solutions to unique problems.
Possesses the ability to think and act with regard to multiple functions with exceptional follow-up skills.
Proficient with standard computer software.
Must be able to effectively manage multiple projects at one time.
Strong Project Management skills.
Strong communication skills (both written and oral).
Ability to work independently or with a group.

Responsibilities

Maintains and adheres to applicable Corporate and Divisional Policies and procedures.
Represents CDSM activities as a member of the Clinical Study Team.
With guidance, 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.
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 QA, GPAS, and clinical team partners, ensuring timely availability of clinical supplies.
Forecasts and coordinates the execution of required packaging jobs including retest expiry label updates.
Participates in CDSM Knowledge Management Meetings and presents relevant topics on an ad hoc basis.
Proactively provides input on process improvement opportunities.
Successfully participates in Process Improvement initiatives.
Partners with Clinical Statistics and CDSM Coordination staff to prepare appropriate protocol specific randomization code files and blind breaker envelopes, as required.
Coordinates with CDSM Materials Management to establish study specific distribution plans for shipment of packaged supplies.
Manages inventory of finished goods and ancillary supply through study completion.
Tracks retest dates and subsequent dating extensions of study medication.
With mentoring, participates in troubleshooting and resolving clinical supply related issues ensuring that project needs and priorities are understood by key team members.
Effectively utilizes MS Project to manage key project activities.
With guidance, may be responsible for project management of IVRS/IWRS activities.
Provides input and recommendation to CSPMs / DSMs on project timing, resource requirements, and budget projections.