Manager, Clinical Supply

PCI Pharma Services • Rockford, IL

4d • $86,880 - $97,740

About The Position

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. The Clinical Supply Manager (CSM) supports PCI Clinical Service Customers by bringing PCI’s experience to clinical trial management, providing expertise throughout the clinical study supply lifecycle. The CSM acts as the customer’s advocate within PCI and coordinates the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support the clinical study. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Complete calculations to estimate clinical trial material demand and maintain the clinical supply inventory throughout the clinical trial. Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies. Execute UAT of the drug supply management modules in IRT systems. Work with other project managers to ensure clinical supply depot set-up is complete and monitor depot inventory throughout study. Manage clinical drug supplies, including packaging design and contingency planning Work in an unblinded capacity with secure, confidential study information. Participate any meetings necessary (i.e., CMC, CRO, Clin Ops, IRT, etc.) to help manage expectations and ensure clear communication. Manage the SMART contract budget and initiate COs as needed. Manage site inventories and request manual drug orders as needed. Manage/monitor ancillary and comparator supplies inventories. Provide final drug accountability reports to Clinical group. Coordinate drug return, accountability, and destruction process. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attention to details is an essential function of this position Performs other duties as assigned by Manager. Work with Packaging Project managers to establish a production schedule based on the study supply plan. Review and approve batch documentation.

Requirements

• College Level Mathematical Skills
• Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs, especially Microsoft Office.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
• Ability to Travel
• Bachelor’s Degree required
• 3-5 Years of Clinical Supplies Experience or Project Management experience

Nice To Haves

• Experience at a sponsor company is desired
• Ability to effectively present information to various people as the job requires.
• Ability to work independently and/or part of a team.
• - Ability to display excellent time management skills.
• Ability to display a willingness to make decisions.

Responsibilities

• Complete calculations to estimate clinical trial material demand and maintain the clinical supply inventory throughout the clinical trial.
• Utilize simulation tools and supply chain expertise to determine packaging campaign and distribution strategies.
• Execute UAT of the drug supply management modules in IRT systems.
• Work with other project managers to ensure clinical supply depot set-up is complete and monitor depot inventory throughout study.
• Manage clinical drug supplies, including packaging design and contingency planning
• Work in an unblinded capacity with secure, confidential study information.
• Participate any meetings necessary (i.e., CMC, CRO, Clin Ops, IRT, etc.) to help manage expectations and ensure clear communication.
• Manage the SMART contract budget and initiate COs as needed.
• Manage site inventories and request manual drug orders as needed.
• Manage/monitor ancillary and comparator supplies inventories.
• Provide final drug accountability reports to Clinical group.
• Coordinate drug return, accountability, and destruction process.
• Work with Packaging Project managers to establish a production schedule based on the study supply plan.
• Review and approve batch documentation.

Benefits

• PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

What This Job Offers

• Job Type: Full-time
• Career Level: Manager