Manager, Clinical Supply

4 weeks ago

Burlington, Canada PCI Pharma Services Full time

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 existing experience in clinical trial supplies management to ensure that all clinical supplies are available in appropriate quantities where and when they are needed to support the clinical study. The scope of responsibilities for the CSM will include all aspects of clinical supplies management from planning and forecasting through site and depot inventory management to close out activities. The CSM also acts as the customer’s advocate within PCI communicating customer and trial needs to PCI, coordinating with internal PCI functions to ensure clinical supplies are available when needed. CSMs may also become involved in activities considered ancillary to traditional clinical supply management responsibilities as customer demands require.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Participate in any meetings necessary to manage expectations and ensure clear communication.
- Complete calculations to estimate clinical trial demand for all materials required in the clinical trial including study drug, commercial comparators, and ancillaries.
- Work with the customer and CROs to create plans that forecast demand over time.
- Work with PCI PMs to ensure appropriate depots are set-up and production schedule are established based on the study supply plan.
- Initiate master English label text and manage approvals for label text and artwork.
- Participate in and execute any UAT activities needed in IRT systems.
- Maintain the clinical supply inventory throughout the clinical trial.
- Review and approve any pre-execution batch documentation required including label documents, packaging specifications, and logistics management documents.
- Manage depot and site inventories to ensure sufficient supplies of all materials are available as needed.
- Coordinate the drug return, accountability, and destruction process and provide final accountability reports on demand.
- Manage the SMART contract budget and initiate change orders as needed.
- Work in an unblinded capacity with secure, confidential study information.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
- Attention to details is an essential function of this position
- This position may require overtime and/or weekend work.
- Other duties may be assigned by management as required.

Special Demands:

- Stationary Position: From 1/2 to 3/4 of the day.
- Move, Traverse: Up to 1/4 of the day.
- Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.
- Install, place, adjust, apply, measure, use, or signal: None.
- Ascend/Descend or Work Atop: None.
- Position self (to) or Move (about or to): None.
- Communicate or exchange information: 3/4 of the day and up.
- Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 of the day.

QUALIFICATIONS:
Required:

- Bachelor’s Degree plus 2 years of experience performing Clinical Trial Supply Management or 4+ years of Clinical Supply Management experience.
- Computer Skills: Ability to perform complex computer tasks and have knowledge of various computer programs, especially Microsoft Office.
- Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
- 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.
- Ability to work independently.
- This position is 100% remote. Access to dedicated work space at home is required.
- Travel requirement is mínimal (10%).

Preferred:

- Experience at a sponsor company is preferred.
- Experience in other functions / roles in the drug development process.
- Ability to effectively present information to people in a variety of roles and public settings.
- Excellent time management skills.
- Display a willingness to make decisions.
- Having a service mentality

LI-RS1

Join us and be part of building the bridge between life changing therapies and patients.

Let’s talk future

Equal Employment Opportunity (EEO) Statement:

- PCI Pharma Services is an Equal _
- Opportunity/Affirmative_
- Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, di

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