Project Manager, Clinical Supply
North Chicago, IL - USA
Job Summary
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.
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.
Qualifications :
- Bachelors 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.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more