Remote Senior Clinical Supply Lead

PCI Pharma Services; Rockford (IL); À distance; USD 122 000 - 137 000; Plein temps

Avantages offerts par ce poste

Paid time off

Health insurance (dental & vision)

Flexible spending account

401(k) plan

Résumé du poste

PCI Pharma Services seeks a Senior Clinical Supply Manager for a fully remote role, guiding drug supply planning for Phase I–IV trials, Expanded Access, and global study supply chains. You will act as the primary client liaison across PCI and the client, coordinating information and ensuring timely delivery.

Responsibilities include building supply plans, labeling strategies, MELT coordination, coordinating with packaging PM, and overseeing IRT design, UAT, and depot logistics.

Qualifications

• Bachelor's degree in a related field is required.
• 5–10 years of related experience and training.
• Basic mathematical skills and ability to perform complex calculations.
• Strong proficiency in English (written and spoken) and professional communication.
• Excellent reasoning with ability to interpret complex instructions.

Responsabilités

• Act as Client advocate to manage drug supply throughout the life of the study.
• Interpret clinical protocol to determine drug and ancillary supply requirements.
• 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 Project Manager to establish a production schedule.
• Review and approve packaging batch documentation for blinded Client when requested.
• Contribute to commercial comparator sourcing strategy when needed.
• Support Interactive Response Technology (IRT) design, set up, and maintenance.
• Participate in IRT Requirements gathering and provide input for IRT specs.
• Perform User Acceptance Testing (UAT) according to protocol.
• Release drug supply in IRT system.
• Coordinate site supply parameters and adjust re-supply strategies.

Connaissances

Mathematical skills

Advanced computer skills

Full professional proficiency in英语

Analytical reasoning

Formation

Bachelor's Degree in related field

Description du poste

PCI Pharma Services seeks a Senior Clinical Supply Manager for a fully remote role, guiding drug supply planning for Phase I–IV trials, Expanded Access, and global study supply chains. You will act as the primary client liaison across PCI and the client, coordinating information and ensuring timely delivery.

Responsibilities include building supply plans, labeling strategies, MELT coordination, coordinating with packaging PM, and overseeing IRT design, UAT, and depot logistics.