PRAHS

  • Study Deliver Administrator

    Job Locations - | Denmark
    Posted Date 1 week ago(5/16/2018 6:37 AM)
    ID
    2018-46904
  • Overview

     

    PRA Health Sciences is a Clinical Research Organisation experiencing exceptional growth globally. The people we employ are key to this growth.

     

    People don’t come to PRA to witness the future of clinical development, they come to shape it. With an average of more than 6 former employees returning to PRA each month we can confidently say that the grass is greener at PRA. Come join the movement and discover your passion, your purpose, your PRA.

     

    As a Study Deliver Admistrator (SDA) you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.

     

    Responsibilities

    For this  office-based position fully embedded to our client, the Study Delivery Adminstrator plays a key role in the success of global clinical trials at a local level. The tasks undertaken by a SDA are varied and can include:

     

    •  Assisting with the coordination and administration of clinical studies from the start-up to execution and close-out.
    • Collecting, assisting in preparation, reviewing and tracking of documents for the application process (HA/IEC). Liaising with Investigators, external service providers, CRAs and Lead CRAs during the collection process to support effective delivery of a study and its documents. 
    • Operational responsibility to set-up the local Trial Master File (eTMF) and ISF including tracking of documents. Maintain and close the local TMF (in electronic or paper form depending on study) according to Good Clinical Practice (ICH/GCP). 
    • Contribute to the production and maintenance of study documents, ensuring template and version compliance. Translate or give the appropriate support with the translation of documents when required.
    • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e. Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities
    • Set-up, populate and accurately maintain information in AstraZeneca tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems
    • Additional country-specific tasks depending on country need, as assigned. 

     

     

    As a Study Delivery Administrator you will have the opportunity to experience the full lifecycle of a project and genuinely contribute to drug development and improving patients’ lives.

     

    Qualifications

    You are:

     

    Detail-orientated, passionate and reliable.

     

    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 educational background, either in life-sciences or as a licensed healthcare professional

    · Strong interpersonal skills

    · Proficiency in MS Office

    · The ability to manage multiple priorities simultaneously

    . Very good written and spoken English and Danish

    · A quality-focused mindset

     

     

    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.




    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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