• Clinical Study Manager

    Job Locations - | United Kingdom
    Posted Date 2 weeks ago(6/7/2018 5:59 AM)
  • Overview

    We are proud to have won Pharma Times 'Clinical Research Company of the Year' in 2018 for the fifth consecutive year. We aren’t winning these awards by chance; PRA is being recognised industry-wide for our dedication to the future of clinical development. Most importantly for you, at PRA we recognise that our success is down to our people.


    At PRA we are now searching for an experienced Clinical Study Manager (CSM) based in the UK. 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.


    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. This position is key to good communication and professional relationships with clinical investigators and international colleagues in HQs and CPOs


    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.


    You are:


    To be successful in this position you will have:

    • Previous experience coordinating an internal team (including Clinical Research Associates and Clinical Trial Assistants)
    • Proven strong experience in clinical research
    • Experience in a monitor role or a role overseeing clinical trials
    • Strong interpersonal skills
    • Strong project management skills
    • Working experience in a global team, a team player
    • Ability to work under pressure

    This is a partially home based role - 3 days a week required at client site.


    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.


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