Covance

  • Project Coordinator, DMC

    Job Location(s) US-NJ-Princeton | US-PA-Philadelphia | US-NJ-Newark | US-NC-Raleigh-Durham
    Job Number
    2018-24488
    Job Category
    Drug Safety
    Position Type
    Full-Time
  • Job Overview

    Project Coordinator, Data Monitoring Committee

    **Home-Based may be considered**

     

     

    The selected candidate will coordinate and support activities for Data Monitoring Committees (DMCs) including but not limited to timeline generation, charter development, travel arrangements, meeting organization and preparation, report generation and review, meeting attendance, meeting minutes and expense reporting.  In this role, you will support the development of DMC tracking tools and reports; act as a liaison between the sponsor and the DMC; maintain project-specific documentation, including, but not limited to, Study Master Files (set-up and maintenance), table mockups; assist in the preparation, generation and distribution of SAS output, reports and presentations to internal and external clients; perform quality control of certain DMC deliverables and ensure the delivery of high quality work to internal and external clients through ongoing quality management, review and implementation of appropriate follow-up activities.

     

    Additional responsibilities include:

    • Organize storage and archiving of project documentation.
    • Perform quality control of certain Biostatistics and Statistical Programming deliverables and carry out other departmental activities as assigned.
    • Carry out all activities according to the appropriate Covance SOPs, working within the framework of the Quality Management System and Good Clinical Practice (GCP).
    • Build and maintain good working relationships within the Biostatistics and Statistical Programming department and across functional units.
    • Interact with a high degree of professionalism and discretion.
    • Any other duties as assigned by management. 

     

     

    Education/Qualifications

    • Bachelor’s Degree

    Experience

    • 2 years of experience in the job discipline (includes direct experience with DMCs) and/or at least 2 years of relevant experience (includes experience in the pharmaceutical, biotechnology, or CRO industry in related areas, such as: Clinical, Safety, Data Management).
    • High degree of accuracy with close attention to detail.
    • Functions as a strong team player.
    • Ability to work efficiently with moderate guidance.
    • Ability to effectively balance multiple concurrent priorities.
    • Strong written and verbal communication skills.
    • Proficiency in use of standard software packages including Word, Excel, PowerPoint.
    • The ability to work to tight deadlines while maintaining high standards.
    • Ability to adhere to strict guidelines and codes of practice.
    • Basic knowledge of the overall clinical trial process.
    • Project management and organizational skills.
    • An evident appreciation of the possible impact of day-to-day activities and actions on Covance as a business.
    • A professional approach at all times.

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