PRAHS

  • TMF Coordinator - Boston, MA

    Job Locations - | US-MA-Boston
    Posted Date 3 days ago(6/15/2018 11:39 AM)
    ID
    2018-46855
  • Overview

    Do you want to watch clinical development change, or do you want to be the one to shape it? 

     

    Because we’re hoping you’re here for the latter. 

     

    Who are we? 

    We Are PRA. 

     

    We are over 15,000 employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most. 

     

    Who are you? 

    You are a leader. Challenging situations motivate you to consistently learn more and do more. You want to work with a diverse team, both internally and externally of your role. You are a critical thinker with demonstrated problem-solving skills. You are adaptable to change; it encourages you to strengthen your skill sets and knowledge base. You prefer to take ownership of your tasks and follow them through to successful completion. Quality communication is important to you, as is maintaining positive, collaborative relationships. You are comfortable presenting information in a multitude of settings to a variety of audiences and desire a company that pushes you to keep growing, learning, and doing more. You want to be accountable for the work you do and recognized when you do well. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working. 

     

    Still here? Good. Because if this is you, we’d really like to meet you. 

     

     

    Responsibilities

    What will you be doing?  

    In a nutshell, you will be the main contact for our Clients and Project Teams for various Document Management deliverables. You will answer questions, send out progress reports for your studies, be involved in audits, and ensure all PRA processes are followed, any study risks are mitigated, and any deliverables meet the expectations of PRA and our Clients. You are the expert on your assigned studies and have ownership for their success from start to finish.  The Trial Master File (TMF) Coordinator is responsible for collecting, developing and documenting the requirements for the TMF. To coordinate, monitor and report onkey TMF activities of the project team and other Document Management staff, including TMF Readiness Reviews and final delivery of the TMF. Provides project-specific oversight and training to other Document Management staff and serves as the main Document Management contact for internal and external customers.

     

    Qualifications

    • Proficient working within a Microsoft Office Environment
    • Independent time management and problem-solving
    • Industry knowledge including ICH/GCP, local regulatory authority and clinical development regulations
    • Prior experience using computerized information systems
    • Prior experience in a leadership role
    • Proficient in developing project/process documents
    • Read, write and speak fluent English; fluent in host country language required
    • Some college coursework

    PREFERRED EXPERIENCE:

     

    • 0-3 years of Clinical, Quality, or Information Management experience preferred
    • Possess some general knowledge of clinical trials and basic principles, procedures, and common best practices
    • Strong command of Microsoft Office Suite
    • Demonstrates basic knowledge and understanding of applicable regulations
    • Demonstrates effective, self-sufficient communication skills
    • Displays good interpersonal skills and ability to deal with a variety of personnel 
    • Undergraduatdegree preferred

     

     

    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

    To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.


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