Manager (Project Manager), Clinical Supplies

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

Hybrid Role: 3 days weekly onsite required. 2 days remote based.

Can work in either location: Basking Ridge, NJ or Armonk, NY

What you will be doing:

Responsibilities:

• Supply Planning - Serves as lead logistics manager for the functional area in supply planning, including demand forecasting according to IOPS requirements; Manages supply planning and timelines to ensure alignment with study plans and timelines and overall clinical development plan; Works with clinical logistics management to determine resourcing needs; Provides input to the development of IP-related study documents including protocols, study and pharmacy manuals; Responsible for working within established timelines of investigational product manufacturing, labeling, release, distribution and return/destruction, and/or helping to establish these timelines; Oversees setup and management of IVRS (IWRS)
• Inventory tracking - Manages and tracks investigational product (IP) inventory; advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends.
• Shipments - Oversees IP shipment orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely and compliant shipment and delivery to investigator sites. Page 11 of 19 Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process.
• IVRS - Working knowledge and experience with Interactive Response Technologies (IRT) such as IVRS and IWRS; Work with cross-functional teams to develop specifications and user testing of IRT systems provided by 3rd party vendors. Lead effort for clinical supply management functionality; Monitor and manage clinical supply activities through IRT from study start-up through study closure; Ensure appropriate system documentation is transferred to client for TMF and inspection readiness.
• Temperature excursions - Reviews and evaluates temperature excursion data and communicates stability information to clinical trial managers, CROs, and investigator sites; provides assessments to supply management team regarding excursion trends in each study.
• Returns & Destruction - Reviews drug return and destruction records; communicates with investigator sites, CROs and external vendors to resolve issues. • Authorizes final destruction of drug returns to 3rd party vendor.
• Expiry Management - Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry. Ancillary Supplies • Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors.
• Documentation - Ensures appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File. Provides input to drug kit randomization specifications and reviews and master kit lists; Reviews IVRS specs and reviews IVRS user manuals; Designs, reviews and approves IP-related study tools (for clinical study teams and investigative site use), as needed. Supports inspection team in preparation for and during regulatory agency inspection.
• Study Team Interaction - Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub[1]team(s); Provides input into budgets, SoWs, contracts and timelines for IP-related services; Prepares or provides input into IP-related content for training materials and coordinates training on study procedures; In collaboration with the CTM for study, provides input into IP-related study specific working practices; Establishes study team contacts, roles, responsibilities, and objectives for IP-related services; Develops, manages, and maintains relationships with external partners; Effectively communicates with CROs, shipping and IVRS vendors, study sites and study team members to ensure ongoing successful execution; Acts as point of escalation for IP[1]related issues.
• Vendor Management - Leads management of IP service vendors (performance, quality, timelines, deliverables, costs); Participates in preparation of RFP, assumptions and SOW for CROs and IP services vendors (labeling, packaging, distribution; IVRS/IWRS); Provides input, reviews, and approves vendor study specifications; Serves as point of escalation for vendor-related IP issues as they arise; Reviews and approves/scrutinizes specified costs on vendor invoices against contract, as delegated; Recommends vendors to IOPS and Clinical Study Teams. • May require 25% travel
• Staff Management - Does not supervise staff. May mentor or coach junior Clinical Logistics staff.
• Process Initiatives - Develop and implement process initiatives in accordance with business needs. Metrics Track metrics related to drug supply processes and staff.
• Training - Provide assistance in training and development as needed.
• Reporting - Compiles and reports supply status to study teams and senior management
• Problem solving - Applies knowledge of company policies and standard practices to resolve problems.

You are:

• Education: Bachelors Degree minimum
• Experience:
  • At least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum in clinical supply management (project oversight level)
  • Global Clinical Supply Management experience required
  • Experience with IRT systems
• Flexibility to work in a hybrid role (3 days in office per week)
  • Location: Basking Ridge, NJ or Armonk, NY

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 to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

https://careers.iconplc.com/reasonable-accommodations

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.