PRAHS

  • Clinical Study Manager (CSM) - Romania

    Job Locations - | Romania-Bucharest
    Posted Date 1 week ago(5/15/2018 11:15 AM)
    ID
    2018-46916
  • Overview

    Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.

     

    Position Overview:

     

    Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.

     

    As Clinical Study 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 in general medicine and eye care. 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.

     

    The Clinical Study Manager (CSM) is accountable for planning, executing and reporting on a number of phase II-III clinical studies for a country or cluster, from planning and site feasibility through study close-out, in compliance with internal processes and regulatory requirements. You will ensure good communication and professional relationships with clinical investigators and international colleagues.

    Responsibilities

    Key tasks will include:

     

    • Managing the local team to meet recruitment targets
    • The efficient management of local vendors
    • Timely review of trip reports
    • Targeted and effective study team training
    • Preparation for audits
    • Development of local study tools and procedures
    • Proactive risk management and budget forecasting
    • Accompanying CRAs on on-site visits to ensure protocol compliance at a site level, and to foster positive working relationships with site staff, including Investigators.
    • The CSM also ensures all country CRAs are trained sufficiently for the trial, Identifies training gaps if additional training is required at country level and works with the Study Lead Monitor to develop further training plans. This role does not involve line management, but will involve coordinating, mentoring and managing a cross-functional team

     

    Qualifications

    You are:

     

    A strong communicator, extremely organised and drive innovation.

     

    To be successful in this position you will have:

     

    • Previous experience of managing an internal team (including Clinical Research Associates and Clinical Trial Assistants)
    • A working knowledge of ICH-GCP guidelines and local and international regulatory requirements
    • A proven track record of success in site management and on-site monitoring
    • Strong Interpersonal skills and experience working in a global team, you are a team player 
    • Strong project management skills, previous experience of leading studies at a country-level is preferred
    • Ability to work under pressure
    •  Fluency in English and Romanian

     

    Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA 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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