About the Role
Trial Supply Manager
UNITED STATES
2024-108727
LOGISTICS & SUPPLIES
ICON STRATEGIC SOLUTIONS
REMOTE
About the role
As a Clinical Supplies Project Manager you will be joining the worlds largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
EST or CST time zones highly preferred for this role.
IMP Supply Management Required
IRT experience Required
What you will be doing:
Youwill be responsible fordeveloping 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
Education and Work Experience:
- 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
Knowledge, Skills, and Abilities:
- 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