Clinical Supply Chain Manager
hace 2 semanas
This role will support IQVIAs FSP (Functional Service Provider) offering, being 100% Sponsor-Dedicated.
**Job Overview**
The Manager, Clinical Supply Chain manages the clinical supply activities for assigned clinical programs. The 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**
- Represent Clinical Supply Chain on Clinical Study Teams and provide a high service level to internal stakeholders.
- Works 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 system N-Side) and inventory plans for assigned programs, ensuring alignment with upstream supply integrators.
- Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Integrators to discuss aggregate drug product demand, changes in clinical supply forecasts, and study timelines.
- Maintain routine and timely communication with Investigational Material Supply Chain (IMSC) Operations to discuss the planning and execution of all packaging and labeling work to support clinical trials.
- Coordinate sourcing of co-meds working closely with Procurement, Supply Vendors and Alliance Managers. Ensure delivery of co-meds to IMSC Operations for further packaging and distribution.
- Generate and monitor co-med budgets and spend working closely with Development Project Managers, Clinical Operations and Finance.
- Manages clinical supply inventory, develops inventory reports and monitors upcoming expiry for assigned programs.
- Align efforts among Project Management, Clinical Operations, and Technical Operations for the timing and delivery of clinical supplies for assigned programs.
- Facilitate discussions and decisions on label and packaging design, as needed.
- Support IRT user acceptance testing, develops IRT supply strategy, and oversees ongoing supply activities in the system.
- Leads cross-functional clinical supply status meetings.
**Qualifications**
- Bachelor degree in a related field.
- 3-4 years of work experience in the pharmaceutical industry.
- Experience in clinical supply chain is preferred.
- 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, functionality, and proficiency with excel modeling.
- Competence with computers and technology is essential; to include extensive experience with MS Office Applications is required.
- Experience with 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 is preferred.
- Proficient in the English language.
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