Clinical Project Manager / IrvineClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
Location: Irvine, CA or Fully Remote
Contract Length: 12 months
Pay Rate: $40-47/hr
- 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 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 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).
2+ years total experience in the Pharmaceutical Industry. Preferably experience in one of the following areas:
- Drug discovery (eg, Process Chemistry, Analytical Chemistry)
- Drug development (eg, Formulation)
- Clinical operations (eg, Clinical Project Management)
- Supply chain (eg, Clinical Supplies Project Management)
- Quality Assurance
How to Apply
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