As a Clinical Supplies Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

EST or CST time zones highly preferred for this role.

IMP Clinical Supply Management Required

IRT experience Required

What you will be doing:

You will be responsible for developing 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

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, 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, colour, 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.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.