21 Oct
PCI CAN PCI Pharma Services Canada
Canada
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.
Summary of Objective:
The Sr. SMART Services Senior Clinical Supply Manager (CSM) is responsible for developing drug supply planning strategy and overall management of supplies for all phases of clinical trials, including Phase I-IV, Expanded Access Program, Compassionate Use, international to domestic, and all levels of trial and supply chain complexity.
The Senior CSM role supports PCI Clinical Service Customers by bringing PCI’s clinical supply chain management experience to the clinical trial, and providing expertise throughout the clinical study and program supply lifecycle. The Senior CSM can act as the Client’s single point of contact in coordinating the necessary information between clinical functions, ensuring that clinical supplies are available in appropriate quantities where and when they are needed to support a global clinical study cross-functionally within PCI as well as the Client's organization and other external vendors.
Qualifications:
Required:
- College Level Mathematical Skills Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
- Basic Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
- 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 and/or 5-7 years Clinical Supplies Experience; majority in Clinical Supply Management at Sponsor Company
Preferred:
- Clinical supply chain management at Sponsor company or Clinical Research Organization strongly preferred
- Ability to work within the Client’s team structures and processes
- Working knowledge of general project management process and tools
- Ability to influence others, resolve conflicts, and negotiation skills
- Ability to effectively present information to various people as the job requires.
- Ability to work independently and/or part of a team. multi-task
- Ability to display excellent time management skills.
- Ability to display a willingness to make decisions.
- Strong organizational skills
Essential Duties and Responsibilities:
- Act as Client advocate, assisting with drug supply management throughout the life of the study
- Work in an unblinded capacity with secure, confidential study information
- Provide input for protocol development and amendment as needed Interpret clinical protocol to determine drug and ancillary supply requirements, packaging / labeling design, and supply plan
- Coordinate with Client to generate Master English Label Text (MELT) if needed
- Collaborate with Client and other appropriate stakeholders to establish labeling strategy
- Collaborate with Client and other appropriate stakeholders to establish labeling strategy
- Build drug projections to create a Supply Plan based on finished goods demand and production plans for domestic and international studies, considering drug retest and expiration dating
- Collaborate with PCI Packaging Project Manager (PM) to establish a production schedule based on the study supply plan
- Review and approve packaging batch documentation (pre and post production) on behalf of 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 process and provide input for IRT specification documents
- Perform User Acceptance Testing (UAT) according to a testing protocol (if provided), with focus on functionality, transactions, and reports that relate to drug supply management
- Release drug supply in IRT system
- Collaborate with Client to establish site supply parameters
- Forecast clinical supply demand and manage clinical supply inventory throughout the clinical trial globally.
- This position may require over time extra hours and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager.
Attends Investigator Meetings, as needed. Provides input for protocol development/amendment, as needed.
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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, disability, military eligibility or veteran status, or any other protected status.
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, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level.
We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
▶️ Sr. Manager, Clinical Supply
🖊️ PCI CAN PCI Pharma Services Canada
📍 Canada