Altran

  • Clinical Supply Chain (CSC) Product Sourcing Coordinator & Trial Manager

    Category
    Technical Resourcing
  • Company Overview

    Today’s complex interconnected world demands companies to conceptualize and deliver cutting-edge products and solutions to market faster than ever before. Altran, a global product development partner, collaborates with companies to address the business and technical challenges inherent in developing and supporting complex connected systems.

     

    For over three decades, leading companies and emerging startups in some of the most highly regulated and rapidly evolving industries have relied on Altran to inspire innovation, accelerate time to market, improve predictability, and maximize return on product investment. Altran provides a full complement of technology consulting, software and product development expertise, and engineering services to our client partners in the Aerospace, Automotive, Energy, Industry and Electronics, and Medical and Life Sciences industries.

     

    In North America, Altran is based in Burlington, Massachusetts, with additional offices in Detroit and the Silicon Valley. For more information, visit altran.com

    Job Description

    The mission of the Clinical Supply Chain (CSC) function is to ensure that products are delivered on time and at cost to clinical trials in support of Client’s project portfolio.  The objective is to meet a minimum of 90% of the timeliness in the delivery of clinical supply materials to clinical sites.

    The CSC team supports and provides tactical and operational oversight to Client trials.  The CSC team supports Phase1 through to Phase 4 trials for both new and registered vaccines.

    On a yearly basis, an average of 50 trials associated with up to 15 projects are managed by the CSC team, worldwide, at different stages (preparation, start-up, close-out).

    Responsibilities

    This role involves 2 functions:  Coordinating CSC product sourcing and managing CSC Trials.  Additional detail related to the responsibilities and activities associated with each role are described at the end of this job description. 

     

    This position is based in Swiftwater, Pennsylvania.


     

    Function 1 – CSC Product Sourcing Coordinator:

    Primarily involves sourcing commercial products required for clinical trials.  Those products would either be sourced externally from preferred distributors or internally through inter-departmental product transfers.

    Additional accountabilities would include:

    • Capturing product requests from CSC project managers
    • Interacting with product suppliers (internal/external) to finalize the required product, quantity and delivery time
    • Executing sourcing/booking in the appropriate systems as per procedures in place
    • Coordinating correct and on-time delivery of products to the packaging site
    • Completing required documentation and archiving.

     

    Function 2 – CSC Trials Manager:

    The CSC Trial Manager executes the Supply Master Plan defined by the CSC Project manager and is also responsible for delivering key trial supply documentation.

    The CSC Trial manager contributes to the following teams and activities:

    • Project supply sub-group
    • Clinical Supply Chain team meeting
    • Clinical team meeting.

    Qualifications

    • At least 5 years’ experience working in the pharmaceutical sector, preferably within the supply chain, clinical operations or manufacturing operations.
    • A good understanding of key principles related to clinical and/or pharmaceutical development operations (drugs, vaccines or medical devices).
    • A good understanding of good clinical and/or good manufacturing practices.
    • A good understanding of international logistics operations and contingencies.
    • Demonstrable experience working in complex settings.
    • The ability to handle multiple tasks concurrently.
    • The ability to demonstrate rigor coupled with flexibility while managing inter-personal relationships and facilitating issue resolution.
    • A curious and proactive approach to problem solving.
    • A Bachelor of Science degree (BS), preferably in a Health Sciences, Engineering or a related discipline.
    • Strong command of the English language (writing, reading, speaking) – native or fluent.

     


     

    Must-have and preferable skills:

    • Past exposure to SAP or at least a global ERP system is a must
    • Data analytics and data flow management
    • Documentation management systems and Quality management systems
    • MS Office software (Word, Excel, PowerPoint, Outlook)
    • Collaborative platforms (Sharepoint, eRooms)
    • Project management or purchasing software

     

    Additional Responsibilities & Activities

    Commercial Product Sourcing Execution and Booking:

    The Sourcing coordinator captures from each and every CSC Manager the needs of external products required in clinical trials.  When the needs are sufficiently defined from the clinical team perspective, Sourcing coordinator will define with the CSC manager the timelines for execution of the following tasks:

    • Capture detailed requirements from the CSC manager and/or clinical team: Trade names, presentations, packaging & language, etc.
    • For internal products: Connect with the proper contact person in the material management group to secure the correct product batch number and quantity.
    • For external products: Contact preferred partners to engage in a Request for Proposal:
      • First interactions with the partner might be informal by phone/email
      • Later interactions would be more formal with a formal proposal issued.
    • Review proposed offers/quotes with the CSC manager to make sure all details are taken into consideration (e.g. addresses, quantities, shipment conditions, timelines, etc.) and if needed, the purchasing manager (i.e. for mark-ups or determining the cost to deliver).
    • Booking & sourcing of products:
      • For internal products: Complete the appropriate SAP transactions to secure the transfer of products to the Clinical Supply Chain team.
      • For external products: Once the target product is identified, enter the purchase requisition into the proper system.
    • Follow-up to ensure proper delivery of the products.
    • Close the loop with purchasing/in the SAP system.
    • Alert the CSC manager in the event of a potential issue and/or to flag any potential risks to timelines.

    Expected Deliverables for CSC Trial Operations:

    The CSC Trial manager is responsible for:

    • Organizing product transfers to the packaging unit of the products requested by Clinical Trials along with the associated documentation.
    • Delivering key Trial supply documentation (including writing, review and approvals, per effective procedures), including the following:
      • Label specifications (master labels are in English and get translated by the translation department)
      • Packaging requirements
      • Packaging instructions when a local partner involved
      • Packaging order issuance.
    • Implementing quality control and product release activities.
    • Defining optimal shipment plans and tracking shipping activities so that clinical sites never run out of product.
    • Coordinating the effort and delivery of the global reconciliation report.
    • Quality control of documentation as well as archival of trial supply documentation in accordance with the trial master file requirements.
    • Setting-up, preparing and facilitating working sessions (including kick-off meetings) with key participants (e.g. trial managers, clinical logistics coordinators, clinical statisticians, packaging unit coordinators, quality representatives, shipping unit representatives, etc.).
    • Weekly progress reports to the CSC Project managers in charge.
    • Timely reporting to the CSC Project manager of issues that may impact any commitments made by the CSC Project manager to CSC customers.
    • Providing assistance during conflict resolutions within the CSC team and clinical team.

     

    Supply Chain Tool Administration

    The Clinical Supply Chain team has led an initiative to improve traceability, with the recent implementation of a new application called “Webmodule”. The Webmodule will be a key tool for the Clinical teams, as it allows tracking the Investigational Products along the entire supply chain, from Packaging through to dispensing, including the return and destruction of products. The Webmodule has been deployed throughout Client since the beginning of 2017.

     

    As a secondary role, the CSC sourcing coordinator will support the CSC with the operational use of the Webmodule for all new clinical trials and to support those trials already included in the new process at the time of implementation.

     

    This would include: 

    • Managing data flows with the following source systems ahead of time, prior to the start of trials (to ensure correct data synchronization):
    • IRT (Interactive Response technology) is the system used in Clinical trials to manage the logistics and the random nature of doses. This system is interfaced with the Webmodule. The Clinical team developed a new interface with the new version of the IRT.
    • Manufacturing systems (SAP and NASCA for Client) that send batch information.
    • Implement a data quality check process for the Webmodule users, using a Qlikview application (deployed in Q4).
    • Support each and every CSC Trial manager to perform reconciliations in the Webmodule by troubleshooting data discrepancies.
    • Implement a process for issue resolution and data discrepancies (required by Q4).

    Equal Opportunity/Affirmative Action Employer; M/F/D/V

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