Remote Senior Clinical Supply Manager | Global Trials

PCI Pharma Services; Rockford (IL); Remote; USD 122.000 - 137.000; Vollzeit

Benefits dieser Stelle

Paid time off

Health insurance

401(k) plan

Flexible spending account

Zusammenfassung

PCI Pharma Services is seeking a Senior Clinical Supply Manager to lead drug supply planning across all phases of clinical trials, including I-IV and Expanded Access. This fully remote role involves coordinating with clients and PCI teams to ensure compliant, on-time supply management for international studies.

Responsibilities include protocol interpretation, labeling strategy, budgeting, IRT support, and collaboration with Packaging PMs.

Qualifikationen

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
• Basic Mathematical Skills
• Intermediate computer skills with knowledge of various computer programs
• Full Professional Proficiency: speak, read, and write fluently and accurately
• Very High Reasoning: define problems, collect data, establish facts, and draw conclusions.

Aufgaben

• Act as Client advocate, assisting with drug supply management throughout the life of the study
• Work in an unblinded capacity with secure, confidential study information
• Provide input for protocol development and amendment as needed
• Interpret clinical protocol to determine drug and ancillary supply requirements, packaging/ labeling design, and supply plan
• Coordinate with Client to generate Master English Label Text (MELT) if needed
• Collaborate with Client and other stakeholders to establish labeling strategy
• Build drug projections to create a Supply Plan for domestic and international studies
• Collaborate with PCI Packaging PM to establish a production schedule
• Review and approve packaging batch documentation on behalf of blinded Client when requested
• Contribute to commercial comparator sourcing strategy when needed
• Support IRT design, setup, and maintenance
• Participate in IRT requirements gathering and specification documents
• Perform UAT per testing protocol focusing on transactional reports
• Release drug supply in IRT system
• Collaborate with Client to establish site supply parameters
• Adjust re-supply strategies based on protocol revisions and enrollment trends
• Assist with import/export processes and quality documentation
• Independently manage clinical supplies including packaging design and contingency planning
• Identify and monitor inventory at depots and sites
• Track shipments to depots and sites
• Identify risks and resolve supply issues
• Adjudicate temperature excursions when requested
• Manage SMART contract budget and Change Orders
• Support Client financial planning for global studies
• Attend Client meetings to provide updates and manage expectations
• Coordinate drug return, accountability, and destruction
• Provide final drug accountability reports
• This position may require extra hours/weekends
• Adhere to PCI, cGMP, and GCP policies
• Attendance is essential
• Perform other duties as assigned by Manager/Supervisor.

Kenntnisse

Bachelor's degree

Basic math

Intermediate computer skills

Professional proficiency

High reasoning

Ausbildung

Bachelor's Degree

Tools

MS Excel

MS Office

Jobbeschreibung

PCI Pharma Services is seeking a Senior Clinical Supply Manager to lead drug supply planning across all phases of clinical trials, including I-IV and Expanded Access. This fully remote role involves coordinating with clients and PCI teams to ensure compliant, on-time supply management for international studies.

Responsibilities include protocol interpretation, labeling strategy, budgeting, IRT support, and collaboration with Packaging PMs.