• Interactive Response Technology (IRT) Project Manager

    Job Locations US-MD-Rockville
    Requisition ID
    2018-10233
  • Responsibilities

    Responsible for providing end-to-end Interactive Response Technology (IRT) support to clinical project teams including but not limited to gathering study specific IRT user requirements, creating IRT standards, managing vendor performance, managing and supporting UAT activities, monitoring system change requests, and supporting training & education for stakeholders. Responsible for clinical supply activities for Phase I-IV assigned studies, including coordination of packaging, labeling, and distribution.

    • Execute IRT development process from project kickoff to system go live, ongoing system change control, maintenance, and system closeout.
    • Submit request for proposal and review/modify IRT proposals in conjunction with management.
    • Work with the internal stakeholders and IRT vendors to develop study specific IRT requirements. Responsibilities include collaboration with vendors and internal stakeholders to define requirements and develop implementation plans.
    • Manage UAT activities including coordination of internal stakeholder and CRO participation, and drafting UAT scenarios and performing testing as required. 
    • Manage vendor performance and relationship(s) at the clinical study level. Responsibilities may include performing root cause analysis and identifying corrective/preventative actions, and serving as a point of escalation for vendor issues.
    • Ensure vendor system development processes align with Otsuka Quality Assurance requirements.
    • Monitor system change requests. Works with the clinical project team to identify system changes and ensure completion of the changes through project life-cycle.
    • Monitors and analyzes system change requests, and identifies corrective actions for utilization of standards.
    • Liaise with Clinical Supply Project Leads and Clinical Supplies Forecasting Manager to ensure optimal and effective use of IRT medication management strategies.
    • Provide IRT support in the following areas:
      • Data transfer issue resolution between IRT vendors and internal/external systems.
      • Development/maintenance of relevant documentation, including applicable SOPs, job aids, and guidance documents.
      • Process improvement activities.
      • Training and education for stakeholders including development of training material.
    • Responsible for clinical supplies management of assigned projects, including coordination of packaging, labeling, and distribution

    Qualifications

    • B.A./B.S. Degree in Biology, Life Sciences, Computer Science, or related field
    • Minimum of 5 years of IRT Project Management experience or IRT database design & development
    • High level understanding of clinical supply chain within the pharmaceutical industry.
    • Knowledge of databases, structure, & corresponding tools used to manage, extract, & report data.
    • Working knowledge of clinical research and statistical concepts.
    • Excellent Interpersonal and communication skills
    • Strong problem solving, planning, and organizational skills
    • Ability to set and communicate goals and job standards.
    • Strong detail-oriented, decision-making, negotiation, and multi-tasking skills
    • Experience with e-mail, Windows, word-processing, database, spreadsheet applications) as well as Microsoft Project and PowerPoint
    • Ability to work effectively in a multifunctional team environment.

     

    Travel (approximately 30%)

    Overview

    Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.


    In pharmaceuticals, Otsuka is a leader in the challenging area of maental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.


    Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.


    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

    Disclaimer

    Disclaimer:

    This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

     

    Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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