Covance

  • Start-up Assoc Project Manager

    Job Location(s) AU-Sydney | AU-Melbourne
    Job Number
    2018-25365
    Job Category
    Clinical Trial Support
    Position Type
    Full-Time
  • Job Overview

    Be Quick! Join Covance Flexible Solutions before December 31, 2018 and receive a AUD5,000 sign on bonus*.

     

    We are seeking an exceptional person with study startup experience that is focussed on advancing their career in Clinical Research to the next level.

     

    Our Associate Project Manager, Study Start up Specialists that work for Covance Flexible Solutions provide our client clinical operations team with support to start up clinical Phase I - IV clinical projects in APAC. Based at home or in our office in Sydney you will enjoy working collaboratively alongside some of the best people in the industry to ensure projects run smoothly.

     

    Joining us as a Assoc Project Manager Startup Specialist you will:

    • Provide expertise for local regulations, ICH/GCP and relevant study and Sponsor requirements.
    • When delegated by Start-up Country Manager (SUCM), oversee and ensure quality data and audit readiness.
    • Anticipate and prevent issues and service failures from developing in their study, escalating when appropriate, negotiating when required.
    • Ensure efficient in country execution and local improvements aligned with global requirements.
    • Represent the country’s performance and suggests mitigation actions in agreement with SUCM.
    • When appropriate, take a lead in team meetings to resolve issues and progress the trial
    • Develop Country and Site Specific patient informed consents for compliance to local requirements and protocol with agreement by SUCM.
    • Proactively resolve informed consent and contractual language issues plus other significant barriers to study execution with study sites
    • Oversee start up activities (possibly across a range of studies) to ensure issues are identified, managed and, if necessary, escalated to the appropriate individual
    • Liaise with Covance regulatory regarding document submission requirements
    • Ensure appropriate systems are updated accurately and compliantly, with site information and study dates (projected and actual) ensuring others follow established processes
    • Coach other start-up team members
    • Handle contract and budget Negotiations with study sites

     

    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.

     

    Joining Flexible Solutions (FSPx) you will have: 

    • The opportunity to work across multiple therapy areas and global trials.
    • The option to move your career between Covance Lead trials and CoSource.
    • To receive ongoing training and support provided by both the Client and Covance dedicated Clinical Operations Manager.
    • The opportunity to join a global CRO requiring the best and brightest CRA talent to join and make a difference
    • One set of Client SOPs and see trails run from a pharmaceutical viewpoint

    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.

     

    Discover your potential in a company that truly invests in you. Talk to us to learn more and explore your career. Apply online today.

     

    We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

     

    * Sign on bonuses will be offered to all new to Covance hires that accept jobs working for Covance FSPx business before December 31, 2018.  

     

    Education/Qualifications

    • Bachelor's Degree in science or medical field.

    Experience

    • 4 -6 years of direct clinical research experience.
    • Australia TGA and local Regulatory and ethics submission knowledge
    • Experience working as a SSU Specialist / SSU Project Manager in complex global phase I- IV clinical trials

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