RHO

  • Clinical Supply Manager

    Job Location US-NC-Chapel Hill
    ID
    2018-1381
    Type
    Regular Full-Time
  • Overview

    The Clinical Supply Manager will be responsible for ensuring the clinical supplies needed for all clinical studies managed by Rho are provided on time, within budget, and in accordance with protocol and applicable regulatory requirements. This includes management and oversight of the planning, forecasting, sourcing, packaging, labeling, distribution and return of clinical supplies for commercial and government sponsored Phase 1-4 clinical trials. The successful applicant will collaborate closely as a member of cross-functional study teams that include Project Management, Clinical Operations, Client Support Services, and IXRS Software Development.

    Responsibilities

    Clinical Trial Supply Management (General):

    • Interpret and advise on clinical trial protocols for study supply requirements/challenges

    • Develop study specific Investigational Product Supply Plans and contribute to Pharmacy Manuals and supply related training/instructional materials (i.e., Investigator Meeting and Site Initiation Visit slides, Dosing Cards, Diaries, etc.)

    • Identify supply accountability tracking needs and provide or ensure Master, Pharmacy, Subject Logs are appropriate accordingly

    • Ensure appropriate documentation of IP supply activities is provided to clinical trial teams for the Trial Master File

    • Participate in relevant team meetings providing clinical supply status reports and support

    • Manage supply planning/forecasting to ensure alignment with study activity and timelines

    • Monitor inventory levels at sites and depots through the life of a trial taking preventative actions to avoid potential supply issues; management may be manual or automated depending on study systems utilized

    • Establish and document supply chain for each project as applicable to scope

    • Coordinate procurement of any required commercially sourced supplies

    • Follow-up on reported Temperature Excursions and/or Product Complaints from sites/depots

    • Ensure expiry extensions are provided to depot/sites as needed to support continued use

    • Collaborate with study team, sponsor, and vendors to assure proper distribution of clinical supplies to study sites

    • Manage return and destruction of clinical supplies, with proper documentation of all steps

    Vendor Management/Oversight

    • Lead Vendor recommendations, qualification, and selection
    • Serve as primary point of contact for third party packaging, distribution, and storage Vendors
    • Provide details for and /or review of Request for Proposals, Scopes of Work, Service Agreements, Contracts, etc.
    • Approve the packaging and logistics service agreements
    • Provide input, review, and approval of Vendor study specifications/plans
    • Review and approve vendor invoices against contract and identify out-of-scope activities

    Packaging and Labeling

    • Design/review/approve investigational supply label text and proofs to meet specific country language(s), translations and regulatory requirements
    • Develop/review/approve clinical supply packaging configurations and specifications
    • Plan and coordinate Vendor activities for scheduling and production of labels and primary/secondary packaging of clinical supplies 
    • Liaise with appropriate parties to ensure adequate clinical study supply releases are obtained per applicable regulations (Qualified Person Release, Certificates of Analysis/Compliance, etc.)
    • Coordinate expiry date extensions and re-labeling operations, when applicable
    • Coordinate Post-Production Identification (ID) testing at external vendors
    • Manage maintenance of appropriate quantity of retain samples 

    IXRS (Interactive Voice/Web Response Systems)

    • Work with cross-functional team to develop study-specific IXRS specifications and requirements documents providing IP management perspective
    • Perform unblinded monitoring of IXRS inventory at depots/sites with respect to recruitment
    • Perform unblinded IXRS functionality monitoring to assure resupply generation, etc. occur within defined specifications
    • Post IXRS deployment, manage system updates for supply expiration date extensions, addition of new depot inventory, generation of manual re-supply shipments, evaluation of temperature excursions, etc.
    • Serve as an escalation point of contact for Rho Client Support Services (CSS) for supply related issues received from sites


     

    Qualifications

    • Bachelor’s Degree or higher in health or life sciences
    • 7-15+ years’ experience in the pharmaceutical/ biotechnology industry performing international clinical supply logistics/management
    • Experience interpreting clinical study protocols and developing well-planned, accurately forecasted clinical supply plans/forecasts
    • Thorough knowledge of Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), International Conference on Harmonization (ICH) Guidelines and other applicable global pharmaceutical regulations/guidelines/directives
    • Experience with Interactive Voice/Web Response System (IXRS) design, implementation, user testing and monitoring
    • Proficiency in Microsoft applications (Word, Excel, PowerPoint, Outlook, etc.), Collaborative platforms (e.g., SharePoint, eRooms, Drop Box, Skype for Business), Electronic Data Capture systems, and Inventory Management systems
    • Ability to establish and meet multiple concurrent priorities, deadlines, strategic department goals and objectives
    • Ability to establish and maintain cooperative and effective working relationships with co-workers, managers and clients
    • Willingness and ability to travel domestically and internationally as needed
    • Demonstrated leadership capabilities, effective organizational skills, and excellent verbal and written communication; ability to present in large and group settings
    • The successful candidate will be a team player with integrity, a commitment to quality, and the ability to think critically and creatively in a fast-paced, changing environment

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