Covance

  • Start-up Specialist I

    Job Location(s) AU-Sydney
    Job Number
    2018-21011
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Are you ready to discover you next career at Covance?

    We are seeking an exceptional person with study startup experience that is focussed on building their career in Clinical Research.

     

    Our Clinical Research SSU Specialists provide our clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at Our Sydney office you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.

     

    Joining us as a SSU Specialists you will:

    • Delivery of the Study Start Up (SSU) component of assigned studies within a country or globally. Including accountability for delivery to time, cost and quality for assigned activities
    • Primary contact with investigative sites during site start-up activities
    • Responsible for working with investigative sites to collect the required investigator and regulatory documents for a study and ensuring that the documents meet the specifications required by local regulations, EU Clinical Trial Directive, ICH-GCP, FDA regulations (for IND studies) and/or the study sponsor
    • Responsible for maintenance of site address and personnel information in the study database as well as maintenance of regulatory documents throughout the duration of the clinical trial.
    • Work with staff in Operational Strategy & Planning, Business Development and Operations, to provide feasibility data and other relevant data critical to the ability of the organization to develop evidence-based plans for the successful implementation and conduct of global clinical trials
    • Where applicable, provide logistical support of clinical trial supply coordination

    Covance Australia is committed to providing employees the freedom to grow careers across all phases and areas of clinical trial operations as well as provide regular support to develop your experience even when you are based at a client site.

    About Covance:

    Covance is one of the world’s largest and most comprehensive drug development services companies, with more than 13,000 employees in 60 countries. We began operations Asia Pacific in 1988 and today have more than 1000 employees in 14 countries across the region. Covance has helped pharmaceutical and biotech companies develop one-third of all prescription medicines in the market today.

    Why Covance?

    At Covance, you will join like-minded collaborative professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.

    Education/Qualifications

    • University/College degree (life science preferred), or certification in a related allied health profession from an appropriate accredited institution (e.g., nursing certification, medical or laboratory technology) 

    Experience

    • 2 years’ work experience in clinical research, including a strong working knowledge of the ICH guidelines and FDA, IRB/IEC regulations
    • Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites
    • Strong networking abilities and an ability/willingness to work with internal and external stakeholders across the globe
    • Good organizational and time management skills, excellent communication / writing skills
    • Self-motivation with the ability to work under pressure to meet deadlines, works well independently as well as in a team environment
       

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Tell Us About Yourself

    Not ready to apply? Connect with us to join our talent community.