PRAHS

  • Associate Clinical Trial Manager

    Job Locations (All) | Taiwan
    Posted Date 2 months ago(10/4/2018 1:17 AM)
    ID
    2018-49619
  • 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.

     

    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.

    Responsibilities

    PRA Health Sciences is currently looking to hire an experienced Associate Clinical Trial Manager (ACTM) to join our business and fully integrated into one of our main sponsor partners, via our Strategic Solutions division.

     

    The role of Associate Clinical Trial Manager (ACTM) is expected to assist the Global / Regional Study Manager in the operational execution of clinical studies.  The employee is responsible for performing tasks as assigned by their manager which includes but is not limited to preparing, collecting, and tracking master study level documents and site non-regulatory documents, reviewing, updating, and testing clinical systems, producing reports on clinical status, trends, and metrics, facilitating communication across Allergan departments, supporting the monitoring team and study sites with relevant study information, and supporting clinical operations.  The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. 

     

    The employee is expected to be fully capable of performing all the roles encompassed in the preceding grade levels within the job family as required by the organization.  Other activities, special projects and assignments may be given as required.  As a result the percentage of time spent across both roles for which the employee is responsible for or assisting with will vary depending on project assignments, current development projects and the requirements within the organization as a whole.

     

    The employee must conduct their work activities in compliance with all relevant regulations, ICH, PhRMA, and CFR guidelines as well as all policies, and procedures. Policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements.

    Qualifications

    • A./B.Sc. preferably in science or health-related field
    • Previous experience of clinical study management
    • Oversight or mentoring of more junior study monitors (direct or indirect) preferred

    Knowledge and Skills

     

    Employee must have a good understanding of the following:

    • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
    • Knowledge of concepts of clinical research and drug development
    • General therapeutic area education and training

    In addition to the essential skills, the incumbent must have the ability to:

    • Handle and prioritize multiple tasks simultaneously
    • Work effectively in a team/matrix environment
    • Understand technical, scientific and medical information
    • Handle conflict management and resolution
    • Understand clinical study budgets
    • Plan, organise, project manage and analyse data
    • Demonstrate full competency in Microsoft Office programs

     

    Your health, Your family, Your career — 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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