Clinical Project Manager (Supply Chain) - Remote

Description:

• Forecasts protocol specific bulk drug product requirements, including comparator agents, ancillary supplies, and commodities, including overages.
• Provides input to Clinical Study Teams to influence clinical protocol design to ensure most efficient utilization of supply chain resources.
• Responsible for protocol specific clinical supplies scenario analysis, risk management and contingency planning.
• Authors the study medication and labeling section of the clinical protocol.
• Responsible for the project management of key Clinical Supply Chain activities at the protocol level for Phase 1, 2, 3, 4 and IIS studies of increasing complexity.
• Identifies, develops, communicates, and tracks project timelines, activities, logistics, and milestones.
• This includes forecasting, planning, scheduling, coordination, and execution, ensuring timely availability of investigational drug supplies and related services to clinical sites and depots.
• Translates clinical study design into packaging design.
• Responsible for creating appropriate protocol specific manufacturing and packaging work orders in concert with Third Party and IVRS vendors, QA, clinical team partners etc to ensure timely availability of clinical supplies.
• Develops protocol specific labeling compliant with applicable global regulations.

Qualifications:

• Ability to work collaboratively within the dept as well as cross-functionally including interacting in a tactful, professional, and effective manner
• 5+ years clinical supplies project management experience in the Pharmaceutical Industry
• Ability to manage and prioritize multiple tasks
• Understanding the importance of compliance in a regulated environment and be capable of applying this knowledge to daily work
• Competent in the application of standard business requirements (for example SOPs, Global Regulations)
• Understanding of clinical development and global supply chain requirements
• Good communication skills (both written and oral
• Ability to work effectively and professionally with those in the dept: Clinical, QA, Analytical and any area interface
• Bachelor’s Degree required preferably in physical/biological science, math, engineering, or pharmacy
• Project Management skills

*EOE**

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Technical Certification Bonus:

Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.