Sr. Manager, Clinical Supply

PCI Pharma Services•Rockford, IL

20d•Remote

About The Position

The SMART Services Senior Clinical Supply Manager (CSM) develops drug supply planning strategies and manages supplies for clinical trials across Phases I–IV, Expanded Access Programs, and Compassionate Use programs. The role supports PCI Clinical Service customers throughout the clinical study and program supply lifecycle, applying clinical supply chain management expertise across studies with varying complexity. The Senior CSM may serve as the Client’s single point of contact, coordinating information across PCI, the Client’s organization, and external vendors. The position manages clinical supplies and related planning, packaging, labeling, IRT activities, inventory, shipments, distribution, and returns. It also supports client communication, budget tracking, quality processes, and proactive management of supply risks and issues. This is a fully remote opportunity. The role may require extra hours and/or weekend work and requires adherence to PCI, cGMP, and GCP policies and procedures.

Requirements

Bachelor’s degree in a related field and/or 5–10 years of related experience and/or training.
Basic mathematical skills.
Intermediate computer skills, including the ability to perform more complex computer tasks and use various computer programs.
Full professional proficiency in speaking, reading, and writing for professional needs.
Very high reasoning ability, including defining problems, collecting data, establishing facts, drawing valid conclusions, interpreting technical instructions in mathematical or diagram form, and handling abstract and concrete variables.

Nice To Haves

Clinical supply chain management experience at a Sponsor company or Clinical Research Organization is strongly preferred.
Ability to work within Client team structures and processes.
Working knowledge of general project management processes and tools.
Ability to influence others, resolve conflicts, and negotiate.
Ability to multitask.
Strong organizational skills.

Responsibilities

Act as a Client advocate and assist with drug supply management throughout the study lifecycle.
Work in an unblinded capacity with secure, confidential study information.
Provide input on protocol development and amendments; interpret protocols to determine drug and ancillary supply requirements, packaging and labeling design, and supply plans.
Coordinate with Clients to generate Master English Label Text (MELT) and establish labeling strategies with appropriate stakeholders.
Develop drug projections and supply plans based on finished goods demand and production plans, considering retest and expiration dating for domestic and international studies.
Collaborate with PCI Packaging Project Managers to establish production schedules based on study supply plans.
Review and approve packaging batch documentation before and after production on behalf of blinded Clients when requested.
Contribute to commercial comparator sourcing strategy when needed.
Support IRT design, setup, and maintenance; participate in requirements gathering and provide input on IRT specifications.
Perform User Acceptance Testing according to testing protocols, focusing on drug-supply functionality, transactions, and reports.
Release drug supply in the IRT system and collaborate with Clients to establish site supply parameters.
Adjust resupply strategies by assessing protocol revisions, enrollment rates, inventory usage, and trends.
Consult with PCI Distribution Project Managers to ensure depot strategy, logistics documentation, and setup meet Client requirements.
Assist with import/export processes and quality processes, including gathering documentation for EU Qualified Persons.
Independently manage clinical supplies for multiple complex studies, including packaging design and contingency planning.
Identify, manage, and monitor clinical trial material inventory at depot and site levels, and track shipments to depots and sites.
Identify potential risks, recommend solutions, and resolve clinical supply issues and complaints.
Adjudicate temperature excursions when requested by the Client.
Manage and track the SMART contract budget, initiate Change Orders as needed, and provide information for Client financial planning for global studies.
Attend Client meetings as requested to provide clinical supply updates, manage expectations regarding delivery timelines, and support cross-functional communication.
Coordinate drug return, accountability, and destruction processes, and provide final drug accountability reports to Clients.
Follow PCI, cGMP, and GCP policies, procedures, and rules; perform other duties assigned by the Manager/Supervisor.