Manager (Project Manager), Clinical Supplies

Overview

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

Responsibilities

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 su