Clinical Project Manager II

The Fountain Group is currently seeking a Clinical Project Manager II - for a prominent client of ours. This position is Remote. Details for the position are as follows: Clinical Project Manager II (Non-MD) - Clinical SuppliesPay: $68-75/hr Duration: 12-month contract with potential to extend or convert based on performance and budget Location: Remote within the continental U.S. or On-site in North Chicago, ILPosition SummaryWe are seeking a highly skilled Clinical Project Manager II (Non-MD) with extensive experience in clinical supply chain project management within the pharmaceutical industry. The successful candidate will manage critical clinical supply chain activities at the protocol level for Phase 1-4 and Investigator-Initiated Studies (IIS) of increasing complexity, ensuring timely and efficient delivery of investigational drug supplies and related services.This position will consider 100% remote candidates.Key Responsibilities

• Manage clinical supply chain activities for protocols across Phase 1-4 and IIS studies.
• Forecast, plan, schedule, coordinate, and execute clinical supply operations, ensuring timely availability to clinical sites and depots (forecasting experience is critical).
• Interpret clinical protocols to determine supply needs, including participating countries, number of sites, and patient populations.
• Ensure the right drug is delivered to the right patient at the right time.
• Work with Interactive Response Technology (IRT) to ensure study parameters are correctly implemented.
• Influence clinical protocol design to optimize supply chain resource utilization.
• Translate clinical study designs into packaging and labeling requirements; author study medication and labeling sections of clinical protocols.
• Develop protocol-specific labeling compliant with applicable global regulations.
• Identify, develop, communicate, and track project timelines, logistics, and milestones.
• Create protocol-specific manufacturing and packaging work orders in collaboration with Third Party and IVRS vendors, QA, and clinical teams.
• Conduct protocol-specific scenario analysis, risk management, and contingency planning.
• Forecast bulk drug product requirements, including comparator agents, ancillary supplies, commodities, and overages.

Critical Success Factors

• Strong understanding of clinical development and global supply chain requirements.
• Knowledge of applicable SOPs, global regulations, and compliance in regulated environments.
• Ability to work collaboratively cross-functionally with Clinical, QA, Analytical, and other interfacing teams.
• Strong project management skills with ability to manage and prioritize multiple tasks.
• Excellent written and verbal communication skills.

Qualifications

• Education: Bachelor’s degree in Physical/Biological Sciences, Math, Engineering, Pharmacy, or related field.
• Experience: Minimum 5 years of clinical supplies project management experience in the pharmaceutical industry.
• Preferred: Global clinical supply chain experience, including understanding import/export requirements and international regulations.

Key Words / SkillsForecasting, IRT, Supply Chain, Project Management, Global Clinical Supply, Proactive, Attention to Detail, Communication, Organization. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy