PRAHS

  • Clinical Trial Manager

    Job Locations - | Hungary
    Posted Date 2 months ago(6/29/2018 8:31 AM)
    ID
    2018-47740
  • Overview

    As Clinical Trial Manager, you will be dedicated to one of our global pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.

    Responsibilities

    As a Clinical Team Manager, you will be responsible for the country-level management of a number of studies from feasibility to study archive, and for communicating the progress and status of the studies to other key players within the team. Adopting a quality-focus to your work on complex global studies, your main responsibilities will include:

    • In liaison with the global clinical team, assisting in the development of local trial execution plan and timeline commitments for a country/cluster.
    • Ensuring that study start-up activities and any amendments are conducted and completed on time.
    • Monitoring the status of site budget and contract negotiations as well as the collection and review of essential documents.
    • Ensuring sites are prepared for “Ready to Initiate Site” (checkpoint). Obtain written confirmation about availability of global documents.
    • Ensuring that all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person.
    • Providing training as needed for monitors and any other activities that support site readiness to recruit.
    • Driving the conduct of the trial, tracking and overseeing progress and status.
    • Oversee local clinical team activities to achieve trial timelines and quality execution according to the standards and local and international regulations.
    • Consistently reading / reviewing the content of all monitoring visit reports for the assigned trial to identify trends and issues. Appropriately escalate issues in a timely manner and ensure resolution.
    • Communicating with field monitors on a regular basis to assure proper adherence to protocol, timelines and other trial related topics
    • Leading and chairing local study team meetings, attend and participate in global clinical trial team meetings
    • Tracking trial budget with appropriate trial budget responsible in country.
    • Ensuring that all trial close–out activities are performed, in close cooperation with field monitors and clinical trial head.
    • Overseeing local vendor selection and performance as needed. Serve as main contact for any potentially significant quality/compliance issues and escalate to clinical trial team as required
    • Facilitate internal audits and HA inspections as required.

    Working consistently and efficiently in this role, no two days are the same as you collaborate with other study team members to bring these life-improving treatments to market.

    Qualifications

    You are:

     

    Proactive, collaborative, innovative.

     

    Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

    • A relevant degree or be a licensed health-care professional
    • A thorough knowledge of ICH GCP and an awareness of local and international regulatory authority regulations.
    • A considerable amount of experience in clinical research / clinical operations with at least several years’ experience of managing clinical projects, providing leadership in a country setting.
    • Self-evident experience of leading a clinical team to successful project delivery
    • Finance management and forecasting skills

     

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. At PRA, the benefits just get better and better.

     

    PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.

     

    For more information please visit our website: www.prahs.com

     

     

     

     

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