PRAHS

  • Study Support Associate

    Job Locations - | China-Beijing | China-Shanghai | Singapore
    Posted Date 1 month ago(4/24/2018 10:41 PM)
    ID
    2018-46565
  • Overview

    Who are we?

    We Are PRA.

     

    We are 15,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting live saving drugs into the hands those who need them most.

     

    Who are you?

    You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Senior Study Support Associate, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

     

    Still here? Good. Because if this is you, we’d really like to meet you.

    Responsibilities

    What will you be doing?

     

    As a Study Support Associate, you will be supporting the trial management and operational activities of Phase I through IV clinical studies in accordance with country-specific regulations, ICH Guidelines, Good Clinical Practices (GCPs), and Standard Operating Procedures (SOPs) and Business Practices.  Support the development and refinement of processes and tools in support of TMF management.  Anticipates, identifies, and communicates with Manager any issues that could affect timelines and works to develop alternative solutions.

    • Support the activities associated with initiation, maintenance, and closure of clinical studies and individual investigative sites
    • Ensure all trial operational activities are conducted in accordance with study timelines and company objectives
    • Assist with the creation of the TMF plan
    • Lead the implementation of the activities outlined in the TMF plan
    • Work with CRO to provide oversight for Trial Master File (TMF) held by preferred providers to ensure high quality deliverable
    • Review and contribute to processes and tools in support of maintaining TMF in audit ready condition
    • Assist and/or lead investigator and internal reconciliation/ review of TMF
    • Assist and/or lead preparation for and responses to internal audits and inspections, as needed
    • Mentor and coach other Study Support Services personnel in key job activities and duties
    • Support other trial related operational activities as needed and assigned

    Qualifications

    Education: 

    • Bachelors Degree with a minimum two (2) years experience in the pharmaceutical industry, supporting clinical study conduct in an operational or training capacity. Has demonstrated thorough knowledge of the operational aspects of pharmaceutical studies

    Skills:

    • Has demonstrated analytical and conceptual capability
    • Basic knowledge of GCP and relevant regulations that govern essential documents
    • Advanced organizational and communication skills. Attention to detail
    • Teamwork and motivational skills. Demonstrated negotiation and persuasion skills
    • Demonstrated ability to handle multiple tasks simultaneously and to adjust with changing priorities
    • Competence in the use of personal computers, including experience with word processing, spreadsheets, e-mail, and web browser applications. Experience with clinical trial management systems a plus

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