Clinical Supply Materials Manager
ICON plc
Google Cloud Platform
Clinical Supply Materials Manager
ICON plc
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- You will be helping to develop drug supply planning strategy and overall management of supplies for clinical studies.
- Generates initial and revises drug forecast at study and program level, communicating demand requirements to CMC and other stakeholders.
- Coordinates the procurement activities for comparator and NIMP and/or ancillary supplies.
- Interprets relevant protocol information to develop packaging/labeling design for clinical supplies.
- Establishes distribution strategy and manages packaging/distribution timelines.
- Supports design and set-up of IRT system.
- Coordinates the origination, proofing and transition of clinical study labels.
- Proactively communicates drug supply delivery timelines to appropriate stakeholders.
- Coordinates the required documentation and activities for import and export of clinical supplies.
- Monitors global inventory and proactively communicates with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of a trial.
- Monitors and manages retest dating for assigned study supplies.
- Proactively identifies potential risks, provides corrective plans, and resolves clinical supply issues and complaints.
- Provides information to support financial planning for global studies and monitors drug supply study budget.
- Reviews new proposal requests and determines required clinical supplies management support.
- Provides responses to potential new client request for information related to clinical supplies management
Requirements
- Bachelor degree required. Advanced degree nice to have.
- Drug Forecasting (Off the protocol preferred) or Demand Planning experience required.
- 3 plus years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
- Working knowledge of the Clinical Trial Supply process
- Strong experience and skills in the management of clinical supply chain logistics
- Knowledge of regulations governing investigational products, including GMP and ICH/GCP guidelines
- Working knowledge of project team structure and processes
- Proactive approach to work, identifying potential issues well in advance and bringing them to the attention of appropriate personnel for resolution
- Knowledge of project management and Clinical customer relationship building
- Knowledge of the ‘Customers’ team structures and processes
- Excellent verbal and written communication skills
- Ability to influence others
- Ability to multi-tasks
- Strong organizational skills
- Experience in conflict resolution and negotiation skills
- Knowledge of general computer skills (i.e. MS Word, Excel, PowerPoint, MS Project and Access)
