ICON Strategic Solutions Sr Principal Clinical Supply Specialist in Boston, Massachusetts
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
This is a fully remote role.
Must have Clinical Trial Drug Supply Chain (Phase 2-3 minimum) experience for this role.
What will you be doing?
You will be responsible for developing drug supply planning strategy and overall management of supplies for clinical studies.
What will you be doing?
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
What do you need to have?
Education and Work Experience:
Bachelor degree required.
Advanced degree nice to have.
IRT experience preferred.
Drug Forecasting (Off the protocol preferred) or Demand Planning experience required.
3 plus years of prior experience in Clinical Trial Supply chain as a Senior level Supply Specialist or Project Manager.
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.
Benefits of Working in ICON:
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.
At 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.
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, 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.
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Posted Date 2 days ago (11/27/2022 1:51 PM)
Location : Location US-Remote
ICON Strategic Solutions
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