Clinical Project Manager Supply Chain - Katalyst Healthcares & Life Sciences
Lake County, IL 60002
About the Job
Responsibilities:
- Responsible for the project management of key Clinical Supply Chain activities at the protocol level for and 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 labelling section of the clinical protocol.
- Develops protocol specific labelling 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 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).
- Bachelor's Degree required preferably in physical/biological science, math, engineering or pharmacy.
- 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.
Source : Katalyst Healthcares & Life Sciences
