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Manager, Clinical Supply Jobs
Company | PCI Pharma Services |
Address | Burlington, Ontario, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-10-02 |
Posted at | 8 months ago |
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
- Work with PCI PMs to ensure appropriate depots are set-up and production schedule are established based on the study supply plan.
- Work in an unblinded capacity with secure, confidential study information.
- Attention to details is an essential function of this position
- Other duties may be assigned by management as required.
- Manage the SMART contract budget and initiate change orders as needed.
- Participate in any meetings necessary to manage expectations and ensure clear communication.
- Participate in and execute any UAT activities needed in IRT systems.
- Coordinate the drug return, accountability, and destruction process and provide final accountability reports on demand.
- Complete calculations to estimate clinical trial demand for all materials required in the clinical trial including study drug, commercial comparators, and ancillaries.
- This position may require overtime and/or weekend work.
- Initiate master English label text and manage approvals for label text and artwork.
- Review and approve any pre-execution batch documentation required including label documents, packaging specifications, and logistics management documents.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Manage depot and site inventories to ensure sufficient supplies of all materials are available as needed.
- Maintain the clinical supply inventory throughout the clinical trial.
- Work with the customer and CROs to create plans that forecast demand over time.
- Communicate or exchange information: 3/4 of the day and up.
- Ascend/Descend or Work Atop: None.
- Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
- Position self (to) or Move (about or to): None.
- Install, place, adjust, apply, measure, use, or signal: None.
- Detect, distinguish, or determine: Up to 1/4 of the day.
- Move, Traverse: Up to 1/4 of the day.
- Stationary Position: From 1/2 to 3/4 of the day.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Computer Skills: Ability to perform complex computer tasks and have knowledge of various computer programs, especially Microsoft Office.
- Ability to work independently.
- This position is 100% remote. Access to dedicated work space at home is required.
- Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Bachelor’s Degree plus 2 years of experience performing Clinical Trial Supply Management or 4+ years of Clinical Supply Management experience.
- Travel requirement is minimal (10%).
- Experience at a sponsor company is preferred.
- Experience in other functions / roles in the drug development process.
- Having a service mentality
- Excellent time management skills.
- Ability to effectively present information to people in a variety of roles and public settings.
- Display a willingness to make decisions.
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