PRAHS

  • Clinical Start-Up Specialist

    Job Locations (All) | Singapore
    Posted Date 3 weeks ago(10/4/2018 1:26 AM)
    ID
    2018-49618
  • 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 Clinical Start-up Specialist (CSS) to join our business and fully integrated into one of our main sponsor partners, via our Strategic Solutions division.

    The CSS develops, evaluates, and executes all essential clinical trial documents and clinical trial agreements (CTAs). Aligns execution activities with agreed upon project priorities, timings and quality specifications.  Adheres to all relevant regulations including ICH and PhRMA guidelines and Sponsor's SOPs and policies.

    The employee must conduct their work activities in compliance with all Sponsor's internal requirements and with all applicable regulatory requirements. Sponsor's internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

    The employee will have strong computer skills, good organizational skills, ability to prioritize and a good understanding of clinical study costs.

     

    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 Sponsor's policies, and procedures. Sponsor's policies include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives

    Qualifications

    • A Bachelor's degree in a science or health-related discipline
    • A basic understanding of contracts and negotiations is preferred
    • Master's degree with no direct clinical research experience, or a Bachelor's degree with 0-2 years clinical research experience
    • Basic understanding of Good Clinical Practices, ICH guidelines, PhRMA code, clinical research ethics, and patient privacy laws (plus applicable local regulations, when country-based)
    • Basic understanding of clinical study costs
    • Basic knowledge of concepts of clinical research and drug development
    • Language proficiency in Chinese/Mandarin

     

    Together with a competitive salary, we offer a comprehensive range of benefits and an excellent working environment. As we continue to expand, there will be career opportunities on a truly global scale.

     

    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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