Clinical Drug Supply Manager

Icon Plc•Blue Bell, PA

66d

About The Position

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. 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. 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 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-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-related issues. This role applies to internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, therapeutic area project managers, medical monitors, as well as staff from quality, clinical compliance, regulatory, formulations, and IOPS (CMC, external manufacturing, stability). 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. 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. Contributes to ongoing process improvement initiatives. 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.

Requirements

Bachelor's degree Required. Health Sciences/Biological field preferred
At least 5 years of relevant experience in the biotechnology/pharmaceutical industry, with 3 years minimum managing clinical supply in the clinical research setting
Experience managing the distribution strategy plan for clinical trials required
Experience with forecasting IP supply in clinical trials required
Experience utilizing Excel or working within an ERP system or both required
Experience working with Third party depots required

Nice To Haves

Experience working with and sourcing comparators in clinical trials preferred
Experience creating or contributing to development of Pharmacy manuals preferred
Oncology therapeutic area experience is preferred

Responsibilities

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)
Manages and tracks investigational product (IP) inventory
Advises supply management team of potential shortages and makes recommendations for resupply activities based on usage trends
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
Works with Clinical Logistics Associate to complete this activity and/or manages any/all aspects of the process
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 for TMF and inspection readiness
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
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
Monitors IP expiry data and informs Clinical Supply team and Clinical Trial teams of pending IP expiry
Develop plans for supplying clinical study sites with ancillary supplies, either through in-house initiated supply or working with supply vendors
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
Represents Clinical Logistics/Supply Management on cross-functional study team (s) and/or sub-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-related issues
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 mentor or coach junior Clinical Logistics staff
Develop and implement process initiatives in accordance with business needs
Contributes to ongoing process improvement initiatives
Track metrics related to drug supply processes and staff
Provide assistance in training and development as needed
Compiles and reports supply status to study teams and senior management
Applies knowledge of company policies and standard practices to resolve problems

Benefits

Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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