Onsite Lake County
Length of assignment: 1 year to start
This is an entry level role
This is an onsite role
Open for candidates who are ready to relocate at their own expense
Once they join, they will be onsite 100% but can work Hybrid once they complete their training and can work independently
12 months with possibility of extension and possibilities of conversion as well
Minimum Requirements
- Bachelor’s degree needed
- Supply chain experience or supply chain operations experience needed
- Someone who can follow procedures
- Work with IRT vendors
- GMP
- Clinical trials experience
- Clinical protocols
- Drug supplies forecast for clinical studies
- Interface with CDSM and operations team
- IRT system experience
- Someone who is proactive and has good communication skills
- 2 plus years of experience needed
- Project management experience needed
Education Requirement
- Bachelor’s Degree required preferably in physical/biological science, math, engineering or pharmacy.
Experience
- 2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:
- Drug discovery (e.g., Process Chemistry, Analytical Chemistry)
- Drug development (e.g., Formulation)
- Clinical operations (e.g., Clinical Project Management)
- Supply chain (e.g., Clinical Supplies Project Management)
- Quality Assurance
Major Responsibilities
- Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase I – IV clinical trials
- 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 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
- 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 department as well as cross-functionally including interacting in a tactful, professional and effective manner.
- Ability to work effectively and professionally with those in the department 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).
Please note that this opening requires the individual to work onsite at the client campus.
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