Sr Manager, Global Clinical Supply Chain
Vor 3 Tagen
**Job Summary **(Primary function)
The Senior Manager, Clinical Supply Chain manages the clinical supply activities for assigned clinical programs. The Senior Manager develops and maintains clinical supply plans to include investigational products and co-meds ensuring accurate and continuous supply to assigned clinical programs while reducing risk and minimizing waste.
**Essential Functions of the Job** (Key responsibilities)
- Represent Clinical Supply Chain on Clinical Study Teams and provide a high service level to internal stakeholders.
- Work with Clinical Operations to understand clinical demand requirements and ensures alignment with study teams on clinical supply plans and timelines.
- Develop and maintain clinical supply forecasts (within forecasting systems) for assigned programs, ensuring alignment with upstream supply integrators.
- Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
- Leads cross-functional clinical supply status meetings.
- Coordinate sourcing of co-meds working closely with procurement and supply vendors.
- Ensure delivery of co-meds to operations partners for packaging and distribution.
- Generate and manage co-med budgets in alignments with Development Project Managers.
- Maintain routine and timely communication with Technical Operations of any changes in clinical supply forecasts or study timelines.
- Facilitate discussions and decisions on label and packaging design, as needed.
- Support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply management in the system.
- Participate in development and maintenance of standard operating procedures (SOPs).
**Qualifications **(Minimal acceptable level of education, work experience, and competency)
- Bachelor degree in a related field.
- 3-4 years of work experience in clinical supply chain.
- Knowledge of global clinical trials and the drug development process.
- Knowledge of global pharmaceutical regulatory requirements (e.g. cGMP, GCP).
- Knowledge of IRT system set up and functionality.
- Experience with stochastic forecasting and inventory management tools is preferred
- Strong organizational, analytical, problem solving, and communication skills.
- Must be a dependable self-starter and be capable of working independently on multiple projects with the ability to prioritize tasks and meet deadlines
- Experience in vendor oversight and managing external partnerships
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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