Clinical Project Manager / Irvine

Location: Irvine, CA or Fully Remote

Contract Length: 12 months

Pay Rate: $40-47/hr

Major 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 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).

Experience:

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