Senior Clinical Supply Operations Specialist

As the Senior Clinical Supply Operations Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Hybrid Role: The person in this role would need to be onsite 3 days a week in Basking Ridge, NJ to start for training for 2-3 months.  Once fully trained will reduce to 2 days required weekly onsite.

Local candidates to the NJ location only will be considered. 

The Sr. Clinical Supply Operations Specialist provides support to the Clinical Drug Supply & Logistics group in the Investigational Product (IP) distribution process, ancillary supplies process and comparator procurement process, for one or more molecules across multiple Therapeutic areas; supporting highly complex studies as well as long-term departmental and cross-functional projects and on-going continuous improvement initiatives. This may include leading short-term projects. Activities are performed on time, within budget and with good quality, in compliance with Regulatory Authorities’ regulations / guidelines and Regeneron Standard Operating Procedures (SOPs) / Work Practice Documents (WPDs). This role applies to internally sourced studies and/or CRO/Partnered studies.

What you will be doing:

Solve complex problems, and initiate completion of the following items within broadly defined practices and policies including selecting methods, techniques, and evaluation criteria for obtaining results related to: 

• IP Supply & Inventory Planning:
  • Accountability, Reconciliation, Returns & Destruction (ARRD)
  • Internal System Management including lot creation, batch status, and inventory maintenance
  • Assessment and Oversight activities (risks, stocking levels, trends)
• IP Shipments
  • System and Non-system generated Shipments
  • Depot transfers o Temperature Excursion Management
• IP Supply Monitoring & Activity Documentation (Electronic Trial Master File - eTMF)
  • Expected Document List (EDL) creation
  • eTMF Document Management per regulatory requirements
  • QA/QP Release Management
  • Pack-and-label kit and sequence reconciliation
  • Inspection Readiness activities
  • IRT management activities including IRT Alert management and UAT activities
  • Suspected Serious Non-Compliance support
• Ancillary Supply & Inventory Planning/Management
  • Procurement support (Includes Work Order Management)
  • Vendor RFI support o Supply Planning & Inventory Management
  • Ancillary Supply Plan creation
  • Shipping & Logistics (Includes International Logistics requirements for Ancillaries)
  • Shipping & logistics activities
  • Temperature Excursions
  • Lot management
  • eTMF activities
  • ARRD activities
• Comparator Planning & Management
  • Market Intelligence Reports
  • Quote/PO/Requisition Process Support
  • IMN Creation
  • Document Storage
  • Temperature Excursions
• Financial Forecasting, Budgeting & Planning
  • Forecast Submissions
  • Order Ticket Entry
  • Demand Updates

Work is performed under general direction and reviewed upon completion for adequacy in meeting objectives.

Candidate is expected to participate in determining objectives of assignment and be able to plan schedules and arrange own activities in accomplishing objectives. Candidate will represent CDSL as a prime contact on contracts or projects. He/She will interact with senior internal and external personnel on significant matters often requiring coordination betwe

Minimum Requirements:

• BS/BA degree in a related field. Minimum of 3+ years of experience in the following fields:
• Clinical Supplies
• QA/Regulatory
• Precision Medicine
• Supply Chain
• Manufacturing
• Or equivalent research/commercial biopharma experience

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.