Altran North America

  • Technical Supplies Operations Manager (TSOM), Clinical Supplies SCP

    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 Atlanta, Chicago, Detroit, New Jersey, Silicon Valley and Southern California. For more information, visit altran-na.com.

    Job Description

    Altran is looking to hire a Trial Supplies Operations Manager (TSOM) to support our efforts at our client location in Bridgewater, NJ. The role of the TSOM is to perform study set-up and follow-up tasks related to Clinical Supplies. He or she is the key contact for CTOMs in charge of the study.

     

    Responsibilities

    Study set-up:

    • Receives the ES/protocol and will provide input/comments
    • Captures the requirements (countries list, recruitment curve…) in order to translate the ES into:
      • Packaging specifications,
      • IP/ancillaries and/or devices needs,
      • Survey to define strategy for supplying comparators and ancillaries,
      • Distribution strategy including use of IVRS if needed depending on participating countries.
    • Documentation input: protocol/monitoring plan/CRA presentations
    • Generates Technical Services and Quotations.
    • Initiates label process (form1) and supports relabeling process when needed.
    • Generates IP stock management table.
    • Manages treatment list.
    • Manages customs values.
    • Generates master study schedule for packaging and distribution.

    Follow-up:

    • Checks consistency of IP needs with Clinical current data and update IP needs, master study schedule for packaging and distribution.
    • Generates CSR appendix.
    • Manages destruction and Reconciliation.

    Qualifications

    Education/Experience

    • Bachelor of Science degree (BS) in Health Science, engineering or related discipline. Demonstrated ability to work in complex settings and deadline driven.
    • At least 5 years’ experience in pharmaceutical business required, preferably within supply chain, clinical operations, manufacturing or logistics environments.

    Expected linguistic and transversal management competencies

    • Native or Fluent in English (writing, reading, speaking).
    • Rigor with flexibility in inter-personal relationships
    • Curiosity and proactivity
    • Ability to handle multiple tasks concurrently and facilitator in issue resolution.

    Expected technical skills or experiences

    • Good understanding of key principles of clinical and/or pharmaceutical development operations (in drugs, vaccines or medical devices)
    • Good understanding of good clinical practices and/or good manufacturing practices
    • Good understanding of international logistics operations and contingencies

    Expected Information solution competencies

    • MS Office solutions (word, Excel, PowerPoint, Excel, Outlook)
    • Documentation management systems and Quality management systems
    • Collaborative platforms (SharePoint, eRooms)
    • Other solution: project management, purchasing

     

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

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