RCI-ABBV-33377 Clinical Drug Supplies Project Manager (Pharma/Biotech)

Contract: 12-month contract with potential to extend – Based on performance and business needs

Clinical Project Manager I (Non-MD)

The position is to be on-site.North Chicago, IL 60064

Manager's Update

• An entry-level candidate will work
• Clinical drug supply management
• Working on direct protocols
• Drug supply perspective
• Forecasting face
• Working very closely with the drug supply manager
• Working with logistics as well
• Interface with the packaging sample
• Interface with the clinical drug supply team
• Working with the IRT team as well
• IRT is an automated system
• The client is having a great training program compared to others.
• The mentorship program is there
• Clinical supply project manager experience is required
• Organization and communication skills
• Working on 6 to 10 different trials
• Working with different clinical trails
• Knowledge of IRT
• Forecasting experience is great to have
• Will be providing input to IRT its an automated system
• Will be doing a global study
• Clinical drug supply forecast needs the lifecycle of the clinical study
• Some pharma and clinical supplies is really plus
• Experience with any Drug discovery, Drug development, Clinical operations, Supply chain Project, Quality Assurance
• MD degree candidate can be overqualified
• open for relocation candidate

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 (eg, Process Chemistry, Analytical Chemistry)
• Drug development (eg, Formulation)
• Clinical operations (eg, Clinical Project Management)
• Supply chain (eg, Clinical Supplies Project Management)
• Quality Assurance

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).