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    Study Start Up Specialist - Sydney, Australia - Novo Nordisk

    Novo Nordisk
    Novo Nordisk Sydney, Australia

    2 weeks ago

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    Description
    The position
    The SSUS is involved from site selection to site activation, driving the rapid start-up of clinical trial sites.

    Reporting to the SSU Clinical Research Manager in the Clinical Development Centre (CDC) Oceania, you will be executing the SSU activities in the allocated clinical trials in compliance with local regulations, ICH-GCP (Good Clinical Practice), Novo Nordisk procedures, and protocol requirements for studies conducted in Australia.


    This position requires:

    Mapping of SSU strategy for each site, assigning lead sites as applicable and planning approval timelines in consultation with Trial Managers (TMs).

    Also, involved in the preparation of study budgets in consultation with TMs and negotiating with trial sites including finalisation of Clinical Trial Research Agreements and Indemnities.

    Building and maintaining effective relationship management and collaboration both internally and externally to reduce site activation timelines.

    Proactively identifying any risks in SSU and site activation plans to relevant stakeholders, and developing and implementing mitigation strategies as required.

    Prepares relevant handover documentation to allow TMs and CRAs to effectively manage ongoing and amendment submissions post site activation.

    Ensure that Site Initiation Visits are ready to be scheduled and that site activation documentation is on track as per approved timelines with the TM and in collaboration with the assigned CRA.

    Qualifications Degree or equivalent in life science, medical or pharmacy is essential.

    Solid knowledge of clinical trials ethics and the regulatory approval process in Australia, confirmed with a minimum of 2 years of working experience in clinical research in any applicable function.

    Good knowledge of clinical trial methodology, along with up-to-date knowledge of the clinical trials environment, including ICH GCP, regulatory issues, and Standard Operating Procedures (SOPs).

    Good presentation skills, negotiation abilities, and basic legal experience are desirable.

    Computer literacy and IT skills, including proficiency in Microsoft Office (Word, Excel, and PowerPoint), as well as experience with a variety of internal and external IT systems (e.g., Sponsor Trial Management System (CTMS), Electronic Trial Master File (eTMF), ERM, HREA, Coupa, novoTime).

    Working at Novo Nordisk We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and difficulties.

    For employees at Novo Nordisk, life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work.

    Ultimately, life is why we're all here - to ensure that people can live a life free from chronic disease.

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