Ref #: 33384

Employment type: Permanent - Full-Time

Location: US- Northeast


ICON Global Strategic Solutions is looking for Clinical Trial Supply Specialists who are interested in a remote opportunity. You will be dedicated to one sponsor supporting supply chain coordination to packaging and labeling vendors and overseeing services/deliverables.

About the Job:

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
With our patients at the center 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.

What Will You Be Doing?

•Obtains, reviews, and approves quotes and invoices.
•Negotiates timelines and oversees the project progress to ensure timely release and distribution of the clinical material to depots.
• Collaborates within the CSC and influencing stakeholders to improve services, cost or lead time.
• Responsible for the creation, design, and printing of different label types.
• Facilitates the weekly oversight of vendors and ensures the forecasted projects meet timelines.
• Supports the release of clinical trial material.
• Oversees P & L budget, inventory oversight, and destruction of expired materials.
• Conduct issue resolution activities for supply aspects of clinical studies (e.g., receiving, packaging, inventory)
•Develop strong internal collaboration within CSC and with the vendors to ensure customer satisfaction.
• Develop excellent working relationships with the other groups within Supply Management.
• Manages the outsourced packaging and labelling activities required to meet First-Patient-In date of clinical trials.
•Ensures tracking of project timelines updated in a timely manner.
•Primary contact for assigned orders, engaging with PM’s, quality, and other staff throughout the life of the trial (documentation, meetings, quality communication, etc.).
•Manage events, deviations and CAPAs and implement process improvements (route cause analysis, corrective and preventive actions, impact assessment, organize training, update SOPs)
•Manages all aspects of issue escalation and resolution at the vendor site and internally with ESIQ or QA
•Escalates any timeline issues and any process issues with the vendor through management and any escalation teams as necessary.

What you Need to Have:

•Bachelor’s degree, 2-4 years of experience in a clinical supply related role or Pharm D with limited experience.
•Autonomy in execution and project management oversight of outsourced packaging and labeling orders.
• Depth of knowledge with packaging types, labeling, and project management services
•Process leadership
•General knowledge of GxP principles
•Experience with clinical supply pack/label/distribution, clinical trial operations, project management, pharma/bio research and development, inventory management
•6+ years total experience, and 4+ years of experience in a clinical supply related role
•Ability to work independently with limited coaching

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.