• Clinical Operations Consultant - Trial Administration

    Job Locations US-NJ-Jersey City
    ID
    2018-1234
    # of Openings
    1
    Category
    Clinical Development
  • Overview

    Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

     

    Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

    The Clinical Trial Administrator (CTA) administers, maintains and supports the logistical and administrative aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs). The incumbent is also a pivotal point of contact and support for the clinical trial team.

    Responsibilities

    Duties:

    • Assists with the set up, management and maintenance of electronic Trial Master Files (eTMF), in accordance with GCP.
    • May be involved with set up, management and maintenance of other program/study related files and electronic filing systems.
    • Supports the clinical team regarding preparation of essential clinical trial documentation, ensuring distribution, tracking and filing of documents as applicable.
    • Coordinates with clinical supply staff as needed to ensure adequate availability for study needs.
    • Coordinates management and maintenance of study documents including quality control checks as directed by operations trial leads.
    • Coordinates archiving of study documents as directed by operations trial leads.
    • May support training of new users on eTMF and SOPs.
    • As directed, will arrange and participate in meetings including preparation and distribution of agendas, meeting materials and taking/distributing meeting minutes.
    • Maintains up-to-date study team contact lists.
    • Assists with the review, tracking and processing of payments/invoices related to investigators, consultants and service providers.
    • Performs general clerical duties in support of clinical trials, e.g., copying, faxing, mailing, filing, and making travel/meeting arrangements.
    • Performs additional tasks as required to support Clinical and Technical Operations managers.

    Qualifications

    Qualifications:

    • H.S. Diploma is required; Associate degree or higher is preferred
    • Minimum of 5 years of administrative experience, including at least 2 in the pharmaceutical/biotechnology/CRO industry
    • Experience supporting clinical trials is strongly preferred
    • Basic knowledge of drug development and FDA GCP/ICH regulatory guidelines is strongly preferred
    • Attention to detail and accuracy in work
    • Effective time management and organizational skills
    • Good analytical and problem-solving skills
    • Strong communication skills, both oral and written
    • Ability to operate standard office equipment, including but not limited to computers, printers, telephone systems, copiers and fax machines
    • Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook), MS Project and Adobe Acrobat
    • Willingness to travel 10-15% to support clinical operations objectives

     

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed