Clinical Supplies Project Manager

Clinical Supplies Project Manager - Remote, US

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are looking for a Clinical Supplies Project Manager to provide scientific and technical support to projects that have significant Pharmaceutical Supply Management, and Clinical Supplies activities associated with them and to act as the lead on appropriate project teams. You will be managing global pharmaceutical supply for all phases and pharmaceutical development activities on-going at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of our clients.

What you will be doing:

• Help 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

Job 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
• Cell and Gene Therapy expertise 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
• Knowledge of project management and Clinical customer relationship building

Benefits of Working in ICON:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition t